Rectal Indomethacin in the Prevention of Post-ERCP Pancreatitis

Completed · Phase 2/Phase 3

Conditions studied: Post-ERCP Pancreatitis

In brief

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.

Key facts

Study ID

NCT01912716

Run by

Indiana University

People needed

1037

Starts

2013-07-01

Expected to finish

2018-10-01

Last updated by the study team

2019-07-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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 -

Where it is running

• Indiana University Health — Indianapolis, Indiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Methodist Dallas Medical Center — Dallas, Texas, United States
• Aurora St. Lukes' Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.