Post-endoscopic retrograde cholangiopancreatography pancreatitis (post-ERCP pancreatitis, or PEP) is inflammation of the pancreas that can occur after an ERCP procedure. Rectal indomethacin is commonly given around the time of ERCP to help reduce this risk, but pancreatitis can still occur despite this treatment.
The purpose of this randomized clinical trial is to determine whether adding ice water irrigation of the papilla at the end of ERCP further reduces the risk of post-ERCP pancreatitis compared with rectal indomethacin alone. The papilla is the small opening in the intestine where the bile duct and pancreatic duct drain.
Participants will be randomly assigned to one of two groups. Both groups will receive rectal indomethacin 100 mg. In the intervention group, the doctor will also irrigate the papilla with a total of 250 mL of ice water immediately after the ERCP. Participants and the study team members who assess study outcomes will not know which treatment group the participant was assigned to. Participants will be assessed after ERCP and followed for up to 30 days for pancreatitis and other complications.
Age 18 years or older.
Undergoing ERCP with a native papilla.
Eligible to receive rectal indomethacin.
Able to provide informed consent.
Known allergy, hypersensitivity, or contraindication to indomethacin or rectal NSAIDs.
Active acute pancreatitis at the time of ERCP.
Prior sphincterotomy or absent native papilla.
Prediction of papilla inaccessibility.
Parallel
Rectal Indomethacin
DrugRectal indomethacin 100 mg administered peri-procedurally for prevention of post-ERCP pancreatitis according to institutional practice.
Papillary Ice Water Irrigation
Procedure/SurgeryImmediately after completion of ERCP and before withdrawal of the endoscope, the duodenal papilla will be irrigated with a total of 250 mL of ice water delivered in five 50 mL aliquots through the endoscope working channel under direct endoscopic visualization. The intervention is expected to add approximately 2 minutes to the procedure.
Incidence of Post-ERCP Pancreatitis
Post-ERCP pancreatitis will be defined as new abdominal pain after ERCP with serum amylase or lipase at least three times the upper limit of normal.
Incidence of Post-ERCP Pancreatitis in Participants With Difficult Cannulation
Incidence of post-ERCP pancreatitis among participants meeting the protocol-defined criteria for difficult cannulation.
Incidence of Post-ERCP Pancreatitis in Participants With Pancreatic Duct Cannulation
Incidence of post-ERCP pancreatitis among participants in whom the pancreatic duct is cannulated during ERCP.
Incidence of Post-ERCP Pancreatitis in Participants With High-Risk Features
Incidence of post-ERCP pancreatitis among participants with protocol-defined high-risk features for PEP.
Severity of Post-ERCP Pancreatitis
Severity will be classified according to the Revised Atlanta Classification as mild, moderately severe, or severe acute pancreatitis.
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This trial is not recruiting at the moment. You can still explore other options:
