New study explores preventive scope procedure for pancreatitis patients too frail for surgery

NCT ID NCT07238296

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First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 2 times

Summary

This study looks at whether a preventive endoscopic procedure (sphincterotomy) can lower the risk of future bile duct problems in frail patients who cannot have their gallbladder removed after a bout of pancreatitis caused by gallstones. About 92 adults will be randomly assigned to either get the procedure during their hospital stay or receive standard care without it. The main goal is to see how long it takes for a serious bile duct event to happen within a year.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 92 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. adult patients (above 18 years) 2. naïve papilla 3. evidence of AP based on the Atlanta criteria: * pain in the upper abdomen * serum amylase or lipase concentration \> 3 times the upper limit of normal * imaging features of acute pancreatitis on abdominal imaging 4. high probability of a biliary etiology: * gallstones or biliary sludge on imaging (any type) * dilated common bile duct on imaging defined as \> 8 mm in patients ≤ 75 years or \> 10 mm in patients \> 75 years * abnormal liver enzymes (alanine aminotransferase \[ALT\] two times the upper limit of normal) 5. patients unfit for surgery due to the attending physician's decision e.g. American Society of Anesthesiologists (ASA) class ≥ III; severe heart failure with reduced ejection fraction \<40%, severe uncontrolled hypertension, chronic kidney disease stage four or five Exclusion Criteria: 1. previous cholecystectomy 2. previous endoscopic sphincterotomy or pancreatobiliary stenting 3. ERCP/ES is recommended by the guidelines (3) * sign of cholangitis * presence of CBD stone on any imaging * signs of stone in endoscopic ultrasonography or magnetic resonance imaging in case of abnormal liver enzymes (persistently elevated ALT and aspartate aminotransferase (AST) with less than a 20% decrease over four days) or dilated CBD (defined as above) 4. chronic pancreatitis 5. estimated life expectancy \< 12 months 6. ERCP is contraindicated, e.g. the procedure cannot be carried out safely due to the patient's comorbidities or physical status; high risk of bleeding or contraindication of the discontinuation of the anticoagulation therapy. 7. ERCP is technically not feasible due to altered anatomy, e.g., total gastrectomy, Roux-en-Y gastric bypass anatomy 8. pancreatobiliary malignancy

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Conditions

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