Prophylactic Sphincterotomy in Acute Biliary Pancreatitis Patients Unfit for Surgery

N/ANot Yet RecruitingNCT07238296

Semmelweis University92 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Acute Biliary Pancreatitis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Recurrent pancreatobiliary events

Composite endpoint: * cholangitis - Tokyo guidelines * recurrent acute biliary pancreatitis - revised Atlanta criteria * choledocholithiasis - imaging/ERCP confirmation * cholangiogenic liver abscess - imaging plus clinical diagnosis

Time frame: 1 year

Secondary Outcomes

Number of participants with recurrent acute biliary pancreatitis, cholangitis, choledocholithiasis, or cholangiogenic liver abscess (individual components of the composite primary outcome)

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).