Phase 3
N=1,037
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
Post-ERCP Pancreatitis
Bottom Line
View on ClinicalTrials.gov: NCT01912716 ↗Enrolled (actual)
1,037
Serious AEs
15.4%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants Who Developed Post-ERCP Pancreatitis — 76; 65 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- high dose indomethacin (Drug); standard dose indomethacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Indiana University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed Post-ERCP Pancreatitis |
76; 65 | — |
| SECONDARY Number of Participants With Moderate or Severe Post-ERCP Pancreatitis |
28; 28 | — |
Summary
It is now established that indomethacin, a non-steroidal anti-inflammatory drug, at a dose of 100 mg, is effective in reducing the frequency and severity of pancreatitis (inflammation of the pancreas) after endoscopic retrograde cholangiopancreatography (ERCP) in high risk patients. However, the optimal dose required is not known. The purpose of this study is to determine whether a dose of 200 mg, administered as rectal suppositories, is more effective than the standard dose of 100 mg. An ERCP procedure is a scope procedure where a lighted tube with a camera is passed down the patient's throat and allows for evaluation of the bile duct and/or pancreatic duct. The most common side effect of this procedure is post-ERCP pancreatitis, or swelling of the pancreas. Some patients are at higher risk for this complication than others. Our hypothesis is to compare the efficacy of these two dose regimens (100 mg vs 200 mg) of prophylactic rectally-administered indomethacin on the frequency and severity of post-ERCP pancreatitis in high-risk patients.
Eligibility Criteria
Inclusion Criteria
Included patients are those undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) and have:
one of the following:
- Clinical suspicion of sphincter of Oddi dysfunction (SOD; type I or II)
- History of post-ERCP pancreatitis (at least one episode)
- Pancreatic sphincterotomy
- Pre-cut (access) sphincterotomy
- greater than 8 cannulation attempts of any sphincter
- Pneumatic dilation of intact biliary sphincter
- Ampullectomy 8.) Assessment for post-sphincterotomy stenosis
OR at least 2 of the following:
- Age less than 50 years old and female gender
- History of recurrent pancreatitis (at least 2 episodes)
- greater than or equal to to 3 pancreatic injections, with at least 1 injection to tail
- Pancreatic acinarization (excluding ventral pancreas of pancreas divisum)
- Pancreatic brush cytology -
Exclusion Criteria
- Unwillingness or inability to consent for the study
- Age less than 18 years
- Intrauterine pregnancy
- Breastfeeding mother
- Standard contraindications to ERCP
- Allergy/hypersensitivity to aspirin or Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Received NSAIDs in prior 7 days (aspirin 325mg or less ok)
- Renal failure (serum creatinine greater than 1.4)
- Active or recurrent (within 4 weeks) gastrointestinal hemorrhage
- Acute pancreatitis (lipase peak) within 72 hours
- Known chronic calcific pancreatitis
- Pancreatic head mass
- Procedure performed on major papilla/ventral pancreatic duct in patient with pancreas divisum (dorsal duct not attempted on injected)
- ERCP for biliary stent removal or exchange without anticipated pancreatogram
- Subject with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram
- Anticipated inability to follow protocol
- Known active cardiovascular or cerebrovascular disease -
Data sourced from ClinicalTrials.gov (NCT01912716). 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.