Adjunctive Cold Water Irrigation Added to Rectal Indomethacin for Prevention of Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis

What this Trial Is About

Researchers are evaluating whether rinsing the papilla with cold water at the end of an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, alongside standard medicine, can reduce the risk of developing pancreatitis, which is the most common major complication after ERCP. This randomized controlled trial is triple-blind and compares the addition of cold water irrigation to rectal indomethacin versus rectal indomethacin with room-temperature water irrigation. The study is led by the University of Kansas Medical Center and focuses on patients aged 20 years and older with a native papilla undergoing ERCP. Participants are randomly assigned to receive either 250 mL of cold water directed in five 50 mL doses or 250 mL of room-temperature water in the same manner, both following a 100 mg rectal indomethacin suppository administered at the end of the ERCP. The water is delivered with aspiration after each aliquot to standardize the procedure and minimize risks. The study ensures patient safety by using guideline-recommended NSAID prophylaxis and continuous monitoring during and after the procedure. During the study, baseline demographic and medical data are collected before the procedure. Patients are closely observed during ERCP and monitored post-procedure for signs of pancreatitis, with laboratory tests performed if there is abdominal pain or suspicion of pancreatitis. The primary outcome is the incidence of post-ERCP pancreatitis between the two groups over approximately 24 to 36 months. Secondary outcomes include assessing the severity of pancreatitis up to 7 days after ERCP. Data is securely recorded in electronic medical records and research databases throughout the study period.

Cold Water Irrigation Therapy as an Adjunct to Indomethacin for Post-Endoscopic Retrograde Cholangiopancreatography(ERCP) Pancreatitis