Trial Outcomes & Findings for Stent vs. Indomethacin for Preventing Post-ERCP Pancreatitis (NCT NCT02476279)

Last Updated: 2024-06-12

Results Overview

Post-ERCP pancreatitis (PEP) was based on a widely validated consensus definition that was applied as a diagnostic framework. In this consensus definition, PEP is diagnosed if there was new onset (or increase) of pain in the upper abdomen, elevation in pancreatic enzymes of at least three times the upper limit of normal 24 h after the procedure, and hospitalization for at least two nights. The outcome was independently adjudicated by 3 ERCP experts at non-enrolling centers based on review of the medical records for study participants who were hospitalized with any adverse event within 2 days of the ERCP. Medical records were redacted of all information that could potentially reveal study group assignment, including radiology reports. The consensus definition was applied as a diagnostic framework so that adjudicators could use their best judgment in cases that did not strictly satisfy the criteria. PEP was declared if there was agreement between at least two of the three adjudicators.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1950 participants

Primary outcome timeframe

Within 48 hours after ERCP

Results posted on

2024-06-12

Participant Flow

Patients were recruited from 20 referral centers in the USA and Canada between September 2015 and January 2023.

Of 7243 patients assessed for eligibility, 1950 met eligibility criteria and were randomly assigned to treatment.

Participant milestones

Participant milestones
Measure	Indomethacin Alone Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
Overall Study STARTED	975	975
Overall Study COMPLETED	974	974
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Indomethacin Alone Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
Overall Study Lost to Follow-up	1	1

Baseline Characteristics

BMI missing for 3 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indomethacin Alone n=975 Participants Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent n=975 Participants Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement	Total n=1950 Participants Total of all reporting groups
Age, Continuous	55.6 years STANDARD_DEVIATION 16.4 • n=975 Participants	55.8 years STANDARD_DEVIATION 16.3 • n=975 Participants	55.7 years STANDARD_DEVIATION 16.4 • n=1950 Participants
Sex: Female, Male Female	599 Participants n=975 Participants	596 Participants n=975 Participants	1195 Participants n=1950 Participants
Sex: Female, Male Male	376 Participants n=975 Participants	379 Participants n=975 Participants	755 Participants n=1950 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	101 Participants n=975 Participants	99 Participants n=975 Participants	200 Participants n=1950 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	866 Participants n=975 Participants	871 Participants n=975 Participants	1737 Participants n=1950 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=975 Participants	5 Participants n=975 Participants	13 Participants n=1950 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=975 Participants	3 Participants n=975 Participants	7 Participants n=1950 Participants
Race (NIH/OMB) Asian	17 Participants n=975 Participants	19 Participants n=975 Participants	36 Participants n=1950 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=975 Participants	2 Participants n=975 Participants	3 Participants n=1950 Participants
Race (NIH/OMB) Black or African American	115 Participants n=975 Participants	102 Participants n=975 Participants	217 Participants n=1950 Participants
Race (NIH/OMB) White	809 Participants n=975 Participants	825 Participants n=975 Participants	1634 Participants n=1950 Participants
Race (NIH/OMB) More than one race	3 Participants n=975 Participants	7 Participants n=975 Participants	10 Participants n=1950 Participants
Race (NIH/OMB) Unknown or Not Reported	26 Participants n=975 Participants	17 Participants n=975 Participants	43 Participants n=1950 Participants
BMI	28.6 kg/m^2 STANDARD_DEVIATION 6.8 • n=972 Participants • BMI missing for 3 participants	29.6 kg/m^2 STANDARD_DEVIATION 7.2 • n=975 Participants • BMI missing for 3 participants	29.1 kg/m^2 STANDARD_DEVIATION 7.0 • n=1947 Participants • BMI missing for 3 participants
Antibiotic use in past 3 months	363 Participants n=868 Participants • Missing in 207 patients (100 in indomethacin plus stent group, 107 in indomethacin alone group) due to question being added in August, 2016.	366 Participants n=875 Participants • Missing in 207 patients (100 in indomethacin plus stent group, 107 in indomethacin alone group) due to question being added in August, 2016.	729 Participants n=1743 Participants • Missing in 207 patients (100 in indomethacin plus stent group, 107 in indomethacin alone group) due to question being added in August, 2016.
Clinical suspicion or known sphincter of Oddi dysfunction	262 Participants n=975 Participants	252 Participants n=975 Participants	514 Participants n=1950 Participants
History of post-ERCP pancreatitis	36 Participants n=975 Participants	24 Participants n=975 Participants	60 Participants n=1950 Participants
History of recurrent pancreatitis	128 Participants n=975 Participants	126 Participants n=975 Participants	254 Participants n=1950 Participants
Difficult cannulation	795 Participants n=975 Participants	823 Participants n=975 Participants	1618 Participants n=1950 Participants
Precut (access) sphincterotomy	112 Participants n=975 Participants	100 Participants n=975 Participants	212 Participants n=1950 Participants
Number of pancreatic injections	0 injections n=973 Participants • Missing in three patients (one in indomethacin plus stent group, two in indomethacin alone group).	1 injections n=974 Participants • Missing in three patients (one in indomethacin plus stent group, two in indomethacin alone group).	1 injections n=1947 Participants • Missing in three patients (one in indomethacin plus stent group, two in indomethacin alone group).
Pancreatic sphincterotomy	58 Participants n=975 Participants	66 Participants n=975 Participants	124 Participants n=1950 Participants
Pancreatic acinarisation	6 Participants n=975 Participants	8 Participants n=975 Participants	14 Participants n=1950 Participants
Biliary sphincterotomy	864 Participants n=975 Participants	869 Participants n=975 Participants	1733 Participants n=1950 Participants
Trainee involvement	555 Participants n=975 Participants	546 Participants n=975 Participants	1101 Participants n=1950 Participants
Total intravenous fluid received during periprocedural period, mL	1796 mL STANDARD_DEVIATION 935 • n=974 Participants • Missing in two patients (one in indomethacin plus stent group, one in indomethacin alone group).	1852 mL STANDARD_DEVIATION 938 • n=974 Participants • Missing in two patients (one in indomethacin plus stent group, one in indomethacin alone group).	1824 mL STANDARD_DEVIATION 937 • n=1948 Participants • Missing in two patients (one in indomethacin plus stent group, one in indomethacin alone group).
Total intravenous lactated Ringer's fluid received during periprocedural period, mL	1554 mL STANDARD_DEVIATION 1052 • n=972 Participants • Missing in five patients (two in indomethacin plus stent group, three in indomethacin alone group).	1606 mL STANDARD_DEVIATION 1085 • n=973 Participants • Missing in five patients (two in indomethacin plus stent group, three in indomethacin alone group).	1581 mL STANDARD_DEVIATION 1069 • n=1945 Participants • Missing in five patients (two in indomethacin plus stent group, three in indomethacin alone group).
Prophylactic pancreatic stent calibre in those who received a stent 3 French	0 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	18 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	18 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent calibre in those who received a stent 4 French	4 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	165 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	169 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent calibre in those who received a stent 5 French	9 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	586 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	595 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent calibre in those who received a stent >5 French	0 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	18 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	18 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent calibre in those who received a stent Missing	3 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	0 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	3 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent length in those who received a stent 2-5cm	7 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	455 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	462 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent length in those who received a stent 6-8cm	3 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	95 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	98 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent length in those who received a stent >8cm	3 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	237 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	240 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.
Prophylactic pancreatic stent length in those who received a stent Missing	3 Participants n=16 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	0 Participants n=787 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.	3 Participants n=803 Participants • Analysis population is those who received a stent. Participants that received a stent in the Indomethacin Alone arm and participants that did not receive a stent in the Indomethacin+ Pancreatic Stent arm are treatment crossovers.

PRIMARY outcome

Timeframe: Within 48 hours after ERCP

Population: Intention-To-Treat and Per Protocol populations

Outcome measures

Outcome measures
Measure	Indomethacin Alone n=975 Participants Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent n=975 Participants Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis Intention-To-Treat Population	145 Participants	110 Participants
The Proportion of Subjects in Each Study Group With Post-ERCP Pancreatitis Per Protocol Population	137 Participants	90 Participants

SECONDARY outcome

Timeframe: Within one month of ERCP

Population: Intention-to-treat and per protocol. Outcome data missing for two participants (one in each treatment arm) and excluded from percentage denominator.

Moderate or severe post-ERCP pancreatitis was based on the consensus definition as a diagnostic framework. For the severity assessment, radiographic information was made available to the adjudicators. The severity was defined as mild post-ERCP pancreatitis resulting in a hospitalization of ≤3 days, moderate post-ERCP pancreatitis resulting in a hospitalization of 4-10 days, and severe post-ERCP pancreatitis resulting in a hospitalization of \> 10 days, or leading to the development of pancreatic necrosis or pseudocyst, or requiring percutaneous or surgical intervention. The outcome was declared if there was agreement between at least two of the three adjudicators.

Outcome measures

Outcome measures
Measure	Indomethacin Alone n=974 Participants Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent n=974 Participants Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis Intention-to-treat population	78 Participants	58 Participants
The Proportion of Subjects in Each Study Group With Moderate-severe Post-ERCP Pancreatitis Per protocol population	74 Participants	45 Participants

Adverse Events

Indomethacin Alone

Serious events: 355 serious events

Other events: 233 other events

Deaths: 24 deaths

Indomethacin+Pancreatic Stent

Serious events: 352 serious events

Other events: 228 other events

Deaths: 26 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Indomethacin Alone n=975 participants at risk Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement	Indomethacin+Pancreatic Stent n=975 participants at risk Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement
Gastrointestinal disorders Abdominal pain	19.0% 185/975 • Number of events 187 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	19.3% 188/975 • Number of events 189 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Gastrointestinal disorders Abdominal pain upper	0.62% 6/975 • Number of events 6 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.31% 3/975 • Number of events 3 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Gastrointestinal disorders Constipation	0.21% 2/975 • Number of events 2 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.51% 5/975 • Number of events 5 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Gastrointestinal disorders Diarrhoea	0.82% 8/975 • Number of events 8 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.62% 6/975 • Number of events 6 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Gastrointestinal disorders Nausea	2.5% 24/975 • Number of events 25 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	1.8% 18/975 • Number of events 18 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Gastrointestinal disorders Vomiting	0.51% 5/975 • Number of events 5 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.92% 9/975 • Number of events 9 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
General disorders Pyrexia	0.82% 8/975 • Number of events 8 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.51% 5/975 • Number of events 5 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Investigations Lipase increased	0.21% 2/975 • Number of events 2 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.51% 5/975 • Number of events 5 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Nervous system disorders Headache	0.31% 3/975 • Number of events 3 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.62% 6/975 • Number of events 6 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.51% 5/975 • Number of events 5 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.00% 0/975 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.72% 7/975 • Number of events 7 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.	0.41% 4/975 • Number of events 4 • Non-serious adverse events were collected from randomization through the Day 5 follow up visit. Serious adverse events were collected from randomization through the end of study (Day 30). Adverse events were assessed at two follow up visits post-randomization: (1) 3-5 days after ERCP and (2) 30 (+/-5) days after ERCP. The follow-up was accomplished by directly contacting the subject or their treating healthcare provider in the event he or she had been hospitalized.

Additional Information

Dr. B. Joseph Elmunzer

Division of Gastroenterology & Hepatology, Medical University of South Carolina

Phone: 8437926982

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place