Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery

Not Applicable

Not yet recruiting

• Conditions: Acute Biliary Pancreatitis

• Registration Number: NCT07238296
• Lead Sponsor: Semmelweis University

Brief Summary

This is a prospective, multicenter, open-label, randomized controlled trial designed to evaluate the efficacy and safety of prophylactic endoscopic sphincterotomy (ES) in frail patients unfit for cholecystectomy following an episode of acute biliary pancreatitis (ABP).

Eligible patients will be randomized in a 1:1 ratio to either prophylactic ES during the index admission or conservative treatment. The primary endpoint is a composite of recurrent pancreatobiliary events within 12 months, including recurrent ABP, cholangitis, choledocholithiasis requiring endoscopic retrograde cholangiopancreatography (ERCP), or cholangiogenic liver abscess. Secondary outcomes include mortality, pancreatobiliary events requiring intensive care unit admission, post-ERCP complications, cholecystitis, and length of hospitalization.

A total of 92 patients will be enrolled. The trial will be led by the Institute of Pancreatic Diseases, Semmelweis University, Budapest, Hungary, and conducted in accordance with Good Clinical Practice.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-22
• Study First Submitted QC: 2025-11-17
• Last Update Submitted: 2025-11-17
• Study First Posted: 2025-11-20
• Last Update Posted: 2025-11-20
• Study Start: 2026-01-01
• Primary Completion: 2026-11-01
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 92

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recurrent pancreatobiliary events	1 year	Composite endpoint: * cholangitis - Tokyo guidelines; * recurrent acute biliary pancreatitis - revised Atlanta criteria; * choledocholithiasis - imaging/ERCP confirmation; * cholangiogenic liver abscess - imaging plus clinical diagnosis

Secondary Outcome Measures

Name	Time	Method
Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)	At 3, 6, 9, and 12 months.	Each component event will be reported separately as the number of participants experiencing the event during follow-up. Definitions: recurrent acute biliary pancreatitis (revised Atlanta criteria), cholangitis (Tokyo guidelines), choledocholithiasis (imaging/ERCP-confirmed bile duct stone), cholangiogenic liver abscess (imaging and clinical diagnosis).
Length of hospitalization	From enrollment to one month.	The number of days from hospital admission until discharge, as determined by the treating physician based on clinical stability and institutional criteria. Results will be reported as days of hospitalization per participant, summarized using descriptive statistics (mean, median, interquartile range and standard deviation).
Pancreatobiliary events requiring intensive care unit admission	At 3, 6, 9, and 12 months.	Number of pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess) resulting in intensive care unit admission. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
Mortality associated with pancreatobiliary events	At 3, 6, 9, and 12 months.	Deaths directly attributable to pancreatobiliary events (recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, cholangiogenic liver abscess), adjudicated by the study committee. Events will be defined according to standard criteria (revised Atlanta criteria for pancreatitis, Tokyo guidelines for cholangitis, imaging/ERCP confirmation for choledocholithiasis, and imaging plus clinical diagnosis for liver abscess).
All-cause mortality	At 3, 6, 9, and 12 months.	Death from any cause during follow-up.
Acute cholecystitis	At 3, 6, 9, and 12 months.	Incidence of acute cholecystitis (Tokyo Guidelines).
Post-endoscopic retrograde cholangiopancreatography pancreatitis	Peri-procedural.	Incidence of pancreatitis (revised Atlanta-criteria) following endoscopic retrograde cholangiopancreatography, with focus on moderate and severe cases
Other endoscopic retrograde cholangiopancreatography-related complications	Peri-procedural.	Incidence of adverse events related to endoscopic retrograde cholangiopancreatography, including bleeding, cholangitis, and perforation.; Complications will be defined according to clinical, laboratory, endoscopic, and imaging findings, and classified by severity based on the need for intervention, hospitalization, or prolonged recovery.