Trial Outcomes & Findings for Rectal Indomethacin to Prevent Post-ERCP Pancreatitis (NCT NCT02002650)

NCT ID: NCT02002650

Last Updated: 2016-06-29

Results Overview

Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2600 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2016-06-29

Participant Flow

From Dec 15, 2013 to Sep 21, 2015, 5325 consecutive patients undergoing ERCP in six centers in China were considered for the study.

After screening, 2725 patients were excluded: 193 did not meet inclusion criteria, 2304 met exclusion criteria and 228 patients declined to participate.

Participant milestones

Measure	Pre-ERCP Group Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
Overall Study STARTED	1297	1303
Overall Study COMPLETED	1297	1303
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Baseline characteristics by cohort

Measure	Pre-ERCP Group n=1297 Participants Pre-ERCP rectal Indomethacin in all patients. Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group n=1303 Participants Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.	Total n=2600 Participants Total of all reporting groups
Age, Continuous	62 years n=5 Participants	63 years n=7 Participants	62 years n=5 Participants
Sex: Female, Male Female	688 Participants n=5 Participants	693 Participants n=7 Participants	1381 Participants n=5 Participants
Sex: Female, Male Male	609 Participants n=5 Participants	610 Participants n=7 Participants	1219 Participants n=5 Participants
High-risk patients	305 participants n=5 Participants	281 participants n=7 Participants	586 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Subjects were diagnosed with post-ERCP pancreatitis if they experienced new upper abdominal pain, serum amylase elevation at least three times the upper limit of normal 24 hours after the procedure, and hospitalization prolonged at least two nights.

Outcome measures

Measure	Pre-ERCP Group n=1297 Participants Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group n=1303 Participants Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
Post-ERCP Pancreatitis	47 participants	100 participants

SECONDARY outcome

Timeframe: 30 days

Moderate pancreatitis requiring hospitalization of 4-10 days. Severe pancreatitis requiring hospitalization for more than 10 days, or hemorrhagic pancreatitis, phlegmon or pseudocyst, or intervention (percutaneous drainage or surgery).

Outcome measures

Measure	Pre-ERCP Group n=1297 Participants Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group n=1303 Participants Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
Moderate-to-severe Pancreatitis	11 participants	23 participants

Adverse Events

Pre-ERCP Group

Serious events: 15 serious events

Other events: 26 other events

Deaths: 0 deaths

Post-ERCP Group

Serious events: 15 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pre-ERCP Group n=1297 participants at risk Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group n=1303 participants at risk Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
Gastrointestinal disorders Moderate to severe bleeding	0.62% 8/1297 • Number of events 8 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.46% 6/1303 • Number of events 6 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Infections and infestations Moderate to severe biliary infection	0.54% 7/1297 • Number of events 7 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.69% 9/1303 • Number of events 9 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.

Other adverse events

Measure	Pre-ERCP Group n=1297 participants at risk Pre-ERCP rectal Indomethacin in all patients. Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients.	Post-ERCP Group n=1303 participants at risk Post-ERCP rectal Indomethacin in high-risk patients. Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not.
Gastrointestinal disorders Mild bleeding	0.39% 5/1297 • Number of events 5 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.31% 4/1303 • Number of events 4 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Infections and infestations Mild biliary infection	1.2% 15/1297 • Number of events 15 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	1.8% 24/1303 • Number of events 24 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Gastrointestinal disorders Mild perforation	0.08% 1/1297 • Number of events 1 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.00% 0/1303 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Infections and infestations Pulmonary infection	0.15% 2/1297 • Number of events 2 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.38% 5/1303 • Number of events 5 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.
Gastrointestinal disorders Incomplete bowel obstruction	0.23% 3/1297 • Number of events 3 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.	0.00% 0/1303 • 30 days Adverse events related to ERCP or indomethacin include bleeding, perforation, biliary infection, cardiovascular or renal adverse events and other adverse events.

Additional Information

Hui Luo

Xijing hospital of digestive diseases

Phone: 862984771536

Email: fmmulh@163.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place