Antegrade Transcystic Balloon Dilatation of the Papillary Sphincter During Emergency Laparoscopic Cholecystectomy for Common Bile Duct Stones

North Estonia Medical Centre100 enrolled

Overview

Adult patients diagnosed with common bile duct stones scheduled for laparoscopic cholecystectomy undergo intraoperative endoscopic sphincteric balloon dilatation (EBD). Postoperatively patients receive a MRT to confirm bile duct clearance. Patients are monitored for 30 day postoperative complications. EBD results are compared with those of ERCP that is more commonly used for bile duct clearance.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Cholelithiasis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Radiographically confirmed (ultrasonography, computed tomography, magnetic resonance cholangiopancreatography) stones in the common bile duct * Eligible for laparoscopic cholecystectomy * Understood and signed written consent form Exclusion Criteria: * Severe cholangitis (according to TOKYO2018 guidelines) * Severe pancreatitis (BISAP score of 3 or more) * Septic shock * Common bile duct stones larger than 15 mm

Locations (1)

North Estonia Medical Centre

Tallinn, Harju, Estonia

Outcomes

Primary Outcomes

Common bile duct clearance

The clearance rate of common bile duct from stones confirmed by post-procedural Magnetic Resonance Cholangiopancreatography (MRCP)

Time frame: 30 days

Secondary Outcomes

Operative time, 30-day post-operative complications, hospital length of stay

The duration of the operation in minutes from incision to skin closure; post-operative complications that were registered within 30 days after the operation, patients' hospital length of stay in days

Time frame: 30 days

Data from ClinicalTrials.gov

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