An interventional study of Ice cold water flushing post ERCP in Post ERCP Pancreatitis, sponsored by Oman Ministry of Health. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by Oman Ministry of Health · Not applicable, Interventional, and Other
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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's planned enrollment of 210 is above the median of 100 across 349 interventional studies indexed under Pancreatitis.
Browse Pancreatitis studies →Oman Ministry of Health is the lead sponsor of 18 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Ice cold water flushing post ERCP
250 mL ice-cold water flush of the ampulla following sphincterotomy,
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.
Time frame: 30 days
No study locations are listed for this record.
Start is estimated for Jun 2026; primary completion for Jun 2027, 12 months later.
Of 91 non-industry interventional studies with no phase under Pancreatitis, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 59. This study's planned 12 months is below that.
Counting every sponsor, half of 94 studies reached it within 32 months; a quarter within 23 and three quarters within 59.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Oman Ministry of Health