Randomized Trial of Rectal Indomethacin and Papillary Spray of Epinephrine Versus Rectal Indomethacin to Prevent Post-ERCP Pancreatitis

Completed · Not applicable

Conditions studied: Post-ERCP Acute Pancreatitis

In brief

This research is being done to see if using a combination of rectal indomethacin and epinephrine spray during endoscopy, can prevent pancreatitis that may occur after ERCP (a type of gastrointestinal endoscopy).

Key facts

Study ID

NCT02116309

Run by

Johns Hopkins University

People needed

948

Starts

2014-08-01

Expected to finish

2016-12-02

Last updated by the study team

2017-11-01

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Major inclusion criteria (If patients meet at least 1 of the criteria):
• History of PEP
• Pancreatic sphincterotomy
• Pre-cut sphincterotomy
• Difficult cannulation (>5 attempts / 10 minutes to cannulate)
• Failed cannulation
• Pneumatic dilation of an intact sphincter
• Sphincter of Oddi dysfunction of Type I or Type II
• Minor inclusion criteria (If patients meet at least 2 of the criteria):
• Age < 50 \& Female gender
• History of acute pancreatitis (at least 2 episodes)
• >/= 3 pancreatic injections (with at least 1 injection in tail)
• Pancreatic acinarization
• Pancreatic Brush Cytology

You may not qualify if…

• Unwillingness or inability to consent for the study
• Age < 18 years
• Intrauterine pregnancy
• Breastfeeding mother
• Standard contraindications to ERCP
• Allergy / hypersensitivity to aspirin or NSAIDs or epinephrine
• Chronic renal disease (Cr > 1.4)
• Active or recent (within 4 weeks) gastrointestinal hemorrhage
• Acute pancreatitis (lipase peak) within 72 hours
• Known chronic calcific pancreatitis
• Pancreatic head mass
• Receiving pancreatic duct stent placement for any indication
• Procedure performed on major papilla/ventral pancreatic duct in patients with pancreas divisum
• ERCP for pancreatic/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
• Sphincter of Oddi dysfunction of Type III

Where it is running

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States
• Asian Institute of gastroenterology — Hyderabad, Andhra Pradesh, India
• Apollo Gleneagles Hospitals — Kolkata, West Bengal, India
• Post Graduate Institute of Medical Education and Research — Chandigarh, India

Full record on ClinicalTrials.gov

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