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

Not Applicable

Completed

• Conditions: Choleclithiasis; Common Bile Duct Stones

• Registration Number: NCT00807729
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 1997-01
• Primary Completion: 2003-07
• Study Completion: 2007-11
• Study First Submitted: 2008-12-10
• Study First Submitted QC: 2008-12-11
• Study First Posted: 2008-12-12
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-02
• Last Update Posted: 2009-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

Inclusion Criteria

• 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:

  1. Common bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan
  2. 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary endpoint was the efficacy of common bile duct stone clearance.	Hospital admmission

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints were length of hospital stay, total cost of index hospitalization, professional fee charges, hospital charges, morbidity and mortality, and patient acceptance and quality of life scores.	Hospitalization

Trial Locations

Locations (1)

San Francisco General Hospital; 🇺🇸 San Francisco, California, United States