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

NCT07677397 | Not Yet Recruiting

• 1 other identifier: MoH/CSR/25/31333
• Study Type: interventional
• Target: 210
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Post ERCP Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard ERCP , no intervention

NO INTERVENTION

Post ERCP flushing

EXPERIMENTAL

Procedure: Ice cold water flushing post ERCP

Interventions

Ice cold water flushing post ERCP PROCEDURE

250 mL ice-cold water flush of the ampulla following sphincterotomy,

Post ERCP flushing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Oman Ministry of Health: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2026
• First Posted: June 30, 2026
• Study Start: June 28, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 30, 2026

Record last verified: 2026-06