Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis

Completed · Not applicable

Conditions studied: Choleclithiasis, Common Bile Duct Stones

In brief

Objective: We compared outcome parameters for good-risk patients with classic signs, symptoms, laboratory and abdominal imaging features of cholecystolithiasis and choledocholithiasis randomized to either LC + LCBDE or ERCP/S + LC. Design: Our study was a prospective trial conducted following written informed consent with randomization by the serially-numbered opaque envelope technique. Setting: Our institution is an academic teaching hospital and the central receiving and trauma center for the City and County of San Francisco. Patients: We randomized 122 patients (American Society of Anesthesiologists Grade I or II) meeting entry criteria. Ten of these patients, excluded from outcome analysis, were protocol violators having signed out of the hospital against medical advice before one of both procedures were completed. Interventions: Treatment was pre-operative endoscopic retrograde cholangiopancreatography sphincterotomy (ERCP/S) followed by laparoscopic cholecystectomy (LC), or laparoscopic cholecystectomy plus laparoscopic common bile duct exploration (LC + LCBDE). Main Outcome Measures: The primary outcome measure was efficacy of stone clearance from the common bile duct. Secondary endpoints were length of hospital stay, cost of index hospitalization, professional fees, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.

Key facts

Study ID

NCT00807729

Run by

University of California, San Francisco

People needed

122

Starts

1997-01-01

Expected to finish

2007-11-01

Last updated by the study team

2009-09-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age > 18 years
• Classic biliary-type pain
• Ultrasonographic demonstration of cholecystolithiasis
• Platelet count > 100,000 per mm³ and prothrombin time < 3 seconds of control
• American Society of Anesthesiology (ASA) risk grade I or II:
• Common bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan
• Intrahepatic duct dilation as determined by ultrasound or CT scan Serum bilirubin greater than 2mg/dl, alkaline phosphatase and/or lipase more than 1.5 times upper limit of normal within 48 hours of intended first pro

You may not qualify if…

• History of bleeding disorders, platelet count <100,000 per mm³ and/or prothrombin time >3 seconds over control
• Uremia as evidenced by a creatinine > 3 mg/dl and/or blood urea nitrogen > 50 mg/dl
• Ultrasonography or CT evidence of cirrhosis, intrahepatic gallbladder, liver mass or abscess, or periampullary neoplasm
• Insulin-dependent diabetes mellitus
• Multiple prior laparotomies
• Morbid obesity
• Clinical, radiologic and/or biochemical evidence of cirrhosis or portal vein thrombosis
• Pregnancy

Where it is running

• San Francisco General Hospital — San Francisco, California, United States

Full record on ClinicalTrials.gov

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