Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
Starting soon · Not applicable
Conditions studied: Post ERCP Pancreatitis
In brief
Endoscopic retrograde cholangiopancreatography (ERCP) is an essential diagnostic and therapeutic tool used to manage diseases of the pancreatic and biliary systems. During the procedure, an upper endoscope is used to reach the major duodenal papilla, and a contrast material is injected into the ducts for radiologic imaging. In an endoscopic sphincterotomy, a specialized knife cuts the biliary sphincter to treat papilla conditions or facilitate therapeutic interventions. The most common complication following an ERCP is pancreatitis, carrying an incidence rate of 3.5% to 9.7%. Standard preventive strategies currently include careful patient selection, rectal administration of NSAIDs (like indomethacin or diclofenac), aggressive intravenous hydration, and pancreatic stent placement. The Innovation: Flushing the ampulla with ice-cold water after a sphincterotomy is a safe,easy, and cost-effective evolving intervention. While initial data demonstrates its safety,there is a clear deficiency in multicenter randomized trials assessing its overall clinical effectiveness, and no such studies have been conducted in the Gulf region. The primary goal of this study is to evaluate the effectiveness of ice-cold water flushing ofthe ampulla after endoscopic sphincterotomy in reducing the incidence of post-ERCP pancreatitis.
Key facts
- Study ID
- NCT07677397
- Run by
- Oman Ministry of Health
- People needed
- 210
- Starts
- 2026-06-28
- Expected to finish
- 2027-06-30
- Last updated by the study team
- 2026-06-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All adults (agesld 18 years old) scheduled for an endoscopic sphincterotomy at the participating hospitals.
You may not qualify if…
- Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent.
Full record on ClinicalTrials.gov
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