Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis (ERCP)

A Multicenter Randomized Controlled Trial of Ice Cold Water Flushing of the Ampulla After Endoscopic Sphincterotomy to Reduce Post-ERCP Pancreatitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Post ERCP Pancreatitis
• Intervention / Treatment: Procedure: Ice cold water flushing post ERCP

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 210
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard ERCP , no intervention
Experimental: Post ERCP flushing	Procedure: Ice cold water flushing post ERCP; 250 mL ice-cold water flush of the ampulla following sphincterotomy,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess whether ice cold water flushing of the ampulla after ERCP reduces incidence of post ERCP pancreatitis compared to no flushing.	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. Specific Objectives: Procedure Efficiency: Compare the time required, success rate of cannulation, and rate of pancreatic stenting between patients who receive the ice-cold water flush and those who do not.; Complication Rates: Contrast post-sphincterotomy complications and the specific severity of post-procedure pancreatitis between the two groups.; Recovery and Burden: Compare the total length of hospital stay and the frequency of hospital revisits within 4 weeks post-procedure.	30 days

Collaborators and Investigators

• Sponsor: Oman Ministry of Health

Study record dates

Study Major Dates

• Study Start (Estimated): June 28, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: June 21, 2026
• First Submitted That Met QC Criteria: June 27, 2026
• First Posted (Actual): June 30, 2026

Study Record Updates

• Last Update Posted (Actual): June 30, 2026
• Last Update Submitted That Met QC Criteria: June 27, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MoH/CSR/25/31333

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No