N/A
N=2,600
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT02002650 ↗Enrolled (actual)
2,600
Serious AEs
1.2%
Results posted
May 2016
Primary outcome: Primary: Post-ERCP Pancreatitis — 47; 100 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pre-ERCP rectal Indomethacin (Drug); Post-operational Rectal Indomethacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Air Force Military Medical University, China
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-ERCP Pancreatitis |
47; 100 | — |
| SECONDARY Moderate-to-severe Pancreatitis |
11; 23 | — |
Summary
Acute pancreatitis is the most common and feared complication of ERCP, occurring after 1% to 30% of procedures. Since 2012, a multicenter RCT was published in NEJM, indomethacin use in high risk patients was considered a "standard" method to prevent PEP. However, the risk factors of PEP is not fully clear. Rectal indomethacin before ERCP for all patients, not just for selected high-risk patients, may preventing PEP maximum. The purpose of this study is to determine whether routine using of rectal indomethacin is more effective than the conditional strategy.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing diagnostic or therapeutic ERCP.
Exclusion Criteria
- Unwillingness or inability to consent for the study;
- Age 1.4mg/dl=120umol/l);
- Active or recurrent (within 4 weeks) gastrointestinal hemorrhage;
- Acute pancreatitis within 72 hours;
- Known pancreatic head mass;
- Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram;
- ERCP for biliary stent removal or exchange without anticipated pancreatogram;
- Known active cardiovascular or cerebrovascular disease.
- Presence of coagulopathy before the procedure or received anticoagulation therapy within three days before the procedure;
Data sourced from ClinicalTrials.gov (NCT02002650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.