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