Trial Outcomes & Findings for Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (NCT NCT02641561)

Results Overview

amylase or lipase

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

192 participants

Primary outcome timeframe

30 days after ERCP

Results posted on

2018-02-27

Participant Flow

Participant milestones

Participant milestones
Measure	A (NS+Placebo) Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
Overall Study STARTED	48	48	48	48
Overall Study COMPLETED	48	48	48	48
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lactated Ringers With or Without Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis	Total n=192 Participants Total of all reporting groups
Age, Continuous	58 years n=5 Participants	62 years n=7 Participants	58 years n=5 Participants	63 years n=4 Participants	60 years n=21 Participants
Sex: Female, Male Female	29 Participants n=5 Participants	33 Participants n=7 Participants	35 Participants n=5 Participants	23 Participants n=4 Participants	120 Participants n=21 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	25 Participants n=4 Participants	72 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	35 Participants n=7 Participants	40 Participants n=5 Participants	40 Participants n=4 Participants	147 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	25 Participants n=21 Participants
Region of Enrollment United States	48 participants n=5 Participants	48 participants n=7 Participants	48 participants n=5 Participants	48 participants n=4 Participants	192 participants n=21 Participants

PRIMARY outcome

Timeframe: 30 days after ERCP

amylase or lipase

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Either Elevated Amylase or Lipase 3 x Upper Limit of Normal	10 Participants	6 Participants	9 Participants	3 Participants

PRIMARY outcome

Timeframe: 30 days after ERCP

Imaging may include Computer Tomography

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Acute Pancreatitis After ERCP as Assessed by Worsening Abdominal Pain Plus Imaging Suggestive of Acute Pancreatitis	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

bilateral opacities on chest imaging not explained by other lung pathology, respiratory failure not explained by heart failure or volume, and overload and a pulmonary arterial oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio under 300, PaO2/FiO2 ratio is the partial pressure arterial oxygen and fraction of inspired oxygen

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Acute Respiratory Distress Syndrome (ARDS) After ERCP as Assessed by ARDSnet Criterion (Below)	1 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Heart rate \> 90 beats per minutes

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10 Participants	6 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Respiratory rate \> 20 breaths per minute

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10 Participants	6 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

PaCO2 \< 4.3 kilopascal (kPa) (32 mmHg)

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Temperature \< 36°C(96.8°F) or \> 38°C(100.4°F)

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10 Participants	6 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

white blood cell (WBC) count \< 4000 cells/mm³ (4 x 109 cells/L)

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

\> 10% immature neutrophils (band forms).

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Systemic Inflammatory Response Syndrome (SIRS) After ERCP as Assessed by the SIRS Criterion (Below)	10 Participants	6 Participants	9 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

positive blood culture

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Sepsis After ERCP as Assessed by Infectious Source Defined by Positive Microbiology Culture	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

creatinine \> 1.5 milligrams/deciliter (mg/dL)

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated Creatinine Blood Test	0 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

INR \> 1.5

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Multiple Organ Failure (MOF) After ERCP as Assessed by Elevated International Normalized Ratio (INR)	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Imaging may include Computer Tomography

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Pancreatic Pseudocyst After ERCP as Assessed by Abdominal Imaging Suggestive of Pseudocyst	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Imaging may include Computer Tomography

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Pancreatic Abscess After ERCP as Assessed by Abdominal Imaging Suggestive of Pancreatic Abscess	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Imaging may include Computer Tomography

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Perforation After ERCP as Assessed by Abdominal Imaging Suggestive of Perforation	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants Who Undergo Surgery After ERCP, as Assessed by Surgical Operative Report	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Mortality After ERCP as Assessed by Medical Record Reporting	1 Participants	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants With Post-procedural Medical Care (ED Visit, Urgent Care, Hospitalization) as Assessed by Medical Record and Patients Self-reporting	6 Participants	2 Participants	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 30 days after ERCP

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Length of Stay (LOS) of Participants After ERCP if Medical Care is Sought as Assessed in Days	2.3 days Standard Deviation 3.5	2.2 days Standard Deviation 4.1	1.9 days Standard Deviation 3.4	4.3 days Standard Deviation 8.4

SECONDARY outcome

Timeframe: 30 days after ERCP

Outcome measures

Outcome measures
Measure	A (NS+Placebo) n=48 Participants Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 Participants Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 Participants Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
The Number of Participants Who Were Readmitted After ERCP as Assessed by Medical Record and Patients Self-reporting	6 Participants	2 Participants	2 Participants	1 Participants

Adverse Events

A (NS+Placebo)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 1 deaths

B (NS+IND)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

C (LR+Placebo)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 2 deaths

D (LR+IND)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	A (NS+Placebo) n=48 participants at risk Normal Saline (intravenous during procedure) + Placebo (100mg suppository per rectum prior to procedure ) Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride. Placebo: Placebo would be a suppository 50 mg x 2	B (NS+IND) n=48 participants at risk Normal Saline (intravenous during procedure) + Indomethacin (100mg suppository per rectum prior to procedure ) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Normal Saline: standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.	C (LR+Placebo) n=48 participants at risk Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Placebo (100mg suppository per rectum prior to procedure) Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis Placebo: Placebo would be a suppository 50 mg x 2	D (LR+IND) n=48 participants at risk Lactated ringer's solution (1 Liter, intravenous prior to procedure) + Indomethacin (100mg suppository per rectum prior to procedure) Indomethacin: Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis Lactated Ringer's Solution: Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
General disorders Acute Renal Failure	2.1% 1/48 • Number of events 1 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	2.1% 1/48 • Number of events 1 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	2.1% 1/48 • Number of events 1 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure
Cardiac disorders Pulmonary Edema	2.1% 1/48 • Number of events 1 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure
General disorders Splenic Laceration	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	0.00% 0/48 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure	2.1% 1/48 • Number of events 1 • 30 days In the case of delayed adverse events (AE), all patients were encouraged to return to the institution in which their procedure was performed. To ensure comprehensive data collection, participants received a telephone call or in person encounter (when hospitalized) within 24 hours and also at 30 days from their procedure

Additional Information

Shaffer R. S. Mok, M.D., M.B.S.

Cooper University Hospital

Phone: 6099804564

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place