University of Kansas Medical Center
This study is designed to learn whether rinsing the papilla with cold water at the end of an ERCP procedure, in addition to standard medicine, can help lower the chance of developing pancreatitis, which is the most common major complication after ERCP.
Study design: This is an investigator-initiated, single-center, triple-blind, parallel-group, randomized controlled superiority trial. Participants will be randomized 1:1 to receive either (1) rectal indomethacin plus cold water irrigation or (2) rectal indomethacin plus room-temperature water irrigation. The study is designed to evaluate whether cold water irrigation provides additive benefit in reducing the incidence of post-ERCP pancreatitis (PEP) compared with standard therapy. Eligible patients (≥20 years, native papilla) undergoing ERCP at University of Kansas Medical Center (KUMC) wil…
Inclusion Criteria: * Native papilla present. * Undergoing ERCP for diagnostic or therapeutic indications. * Able to provide informed consent. Exclusion Criteria: * Post-operative reconstructed intestinal tract other than Billroth I reconstruction. * Acute pancreatitis at the time of ERCP. * Chronic pancreatitis. * Pancreatic head cancer with occlusion of the main pancreatic duct. * Existing pancreatic duct stent or need for prophylactic pancreatic duct stenting during the index ERCP. * Known contraindications or allergy to indomethacin or other NSAIDs. * Significant renal impairment (eGFR…
Rectal indomethacin plus cold water irrigation
Rectal indomethacin plus room-temperature water irrigation
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