A Multicenter Randomized Controlled Trial of Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis
| Registry | NCT07677397, acronym ERCP |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 210 (Estimated) |
| Sponsor | Oman Ministry of Health (Other gov) |
| Conditions | Post ERCP Pancreatitis |
| Interventions | Ice cold water flushing post ERCP (Procedure) |
| Dates | start 2026-06-28 (estimated), primary completion 2027-06-30 (estimated), completion 2027-06-30 (estimated), first posted 2026-06-30, last updated 2026-06-30 |
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All trials for Post ERCP Pancreatitis All trials of Ice cold water flushing post ERCP
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.
This is a multicenter, randomized, controlled trial representing the population of Oman. A total of 210 adult patients (aged 18 and older) undergoing endoscopic sphincterotomy will be randomly assigned in a 1:1 ratio (105 patients per group) using stratified block randomization.The active group will receive a 250 mL ice-cold water flush of theampulla following sphincterotomy, while the control group will receive standard care without the flush.All adults (aged 18 years old and above) scheduled for an endoscopic sphincterotomy at the participating hospitals will be included. Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent will be excluded . Data will be prospectively retrieved from electronic hospital information systems (Trackcare at SQUH; AL-Shifa-3 at RH and NH) via printed data sheets. The results of this pioneering regional study are expected to provoke a shift in standard ERCP practices, successfully lowering patient complication rates and shortening hospital stays. Furthermore, it will build the first dedicated database from the Gulf region to drive future meta-analyses and advance advanced gastrointestinal research.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Standard ERCP , no intervention | No intervention | ||
| Post ERCP flushing | Experimental | Procedure: Ice cold water flushing post ERCP |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * All adults (agesld 18 years old) scheduled for an endoscopic sphincterotomy at the participating hospitals. Exclusion Criteria: * Patients with missing data, acute or chronic pancreatitis, pancreatic cancer, or those unable to provide informed consent.