Indomethacin Decreases Post-ERCP Pancreatitis

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Endoscopic retrograde cholangiopancreatography (ERCP) is now a widely accepted therapy for treating benign and malignant diseases of the pancreatobiliary tree. Acute pancreatitis represents the most common and feared complication following ERCP. The reported incidence of this complication is from 1% to 40% according to the presence of high-risk factors for this complication or the presence dysfunction in the sphincter of Oddi (SOD). In most prospective series, the incidence has ranged between 3.5% and 20% for nonselected and high-risk patients, respectively. Independent risk factors for post-ERCP pancreatitis are either patient- or procedure-related.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto Mexicano del Seguro Social
• Treatments: Glycerol; Indomethacin

Criteria

Inclusion Criteria:

• If they met one or more of the following criteria:

• a clinical suspicion of SOD dysfunction;

• or a history of post-ERCP pancreatitis, pancreatic

• or precut sphincterotomy,

• more than eight cannulation attempts,

• pneumatic dilatation of an intact biliary sphincter,

• or ampullectomy

• Patients were also eligible for inclusion if they met two of the following criteria:

• aged 50 years or younger and female gender

• or a history of recurrent pancreatitis (>2 episodes),

• three or more injections of contrast agent into the pancreatic duct with at least one injection to the tail of the pancreas,

• excessive injection of contrast agent into the pancreatic duct resulting in opacification of pancreatic acini,

• or the need for acquisition of a cytology specimen from the pancreatic duct with the use of a tissue-sampling brush.

Exclusion Criteria:

• unwillingness or inability to consent for the study

• pregnancy

• breast feeding

• standard contraindications for ERCP

• hypersensitivity to aspirin or NSAIDs

• previous use of NSAIDs within 1 week

• renal failure (creatinine clearance rate >1.4 mg/dL)

• active or recent (< 4 weeks) gastrointestinal hemorrhage

• chronic calcified pancreatitis

• pancreatic head malignancy

• any procedure performed on the major papilla/ventral pancreatic duct in patients with a pancreatic divisum

• previous ERCP for biliary stent removal or exchange without an anticipated pancreatogram

• subjects with prior biliary sphincterotomy and scheduled for repeat biliary therapy without an anticipated pancreatogram

• or anticipated inability to follow our protocol