Status:
COMPLETED
Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis
Lead Sponsor:
Indiana University
Collaborating Sponsors:
American College of Gastroenterology
University of Michigan
Conditions:
Post-ERCP Pancreatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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)...
Detailed Description
After obtaining informed consent, subjects will undergo ERCP per clinical protocol. All procedure-related clinical decisions and interventions will be dictated by the performing physician as he or she...
Eligibility Criteria
Inclusion
- 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
- 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 -
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2018
Estimated Enrollment :
1037 Patients enrolled
Trial Details
Trial ID
NCT01912716
Start Date
July 1 2013
End Date
October 1 2018
Last Update
July 5 2019
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University Health
Indianapolis, Indiana, United States, 46202
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425