N/A
Completed N=2,600
Rectal Indomethacin to Prevent Post-ERCP Pancreatitis
Post-ERCP Acute Pancreatitis
Source: ClinicalTrials.gov NCT02002650 ↗
Enrolled (actual)
2,600
Serious AEs
1.2%
Results posted
May 2016
Primary outcomePrimary: Post-ERCP Pancreatitis — 47; 100 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-ERCP Pancreatitis |
47; 100 | — |
| SECONDARY Moderate-to-severe Pancreatitis |
11; 23 | — |
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. Informational only — not medical advice.