Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis
Condition: Choleclithiasis; Common Bile Duct Stones
MeSH terms: Gallstones; Calculi
Study type: Interventional

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.
    

Intervention name(s): ERCP; LapCBDE
Intervention type(s): Procedure; Procedure
Intervention description(s): Endoscopic Retrograde Cholangiopancreatography Patients randomized to ERCP/S + LC were scheduled to undergo the endoscopic procedure using fluoroscopy (OEC Diasonics 9400) in the endoscopy suite under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Duodenal atony during ERCP was routinely achieved using intravenout glucagon. If choledocholithiasis was detected or suspected at the time of ERCP, a sphincterotomy was undertaken so that gallstones could be extracted using a balloon catheter or retrieval basket. Small bowel gas was aspirated endoscopically as much as possible at the conclusion of the ERCP. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP; LC + LCBDE was performed in a routine fashion by one fulltime faculty member (SJR) with fellowship training in laparoscopy. Cholangiograms were obtained fluoroscopically using the same make and model fluoroscope (OEC Diasonics 9400) as used in ERCP by antegrade contrast flushing through the cystic duct. All fluoroscopy was performed by the principal author (SJR) in the presence of and concurrence with the ERCP endoscopist (JPC). When stones were detected or suspected by cholangiography, transcystic exploration was undertaken by balloon or basket with associated balloon dilation of the sphincter of Oddi A completion cholangiogram was obtained to confirm that all stones were removed. Once the LCBDE was completed, the cystic duct was ligated and the gallbladder removed.
Other intervention name(s): ERCP/ laparoscopic cholecystectomy; Laparoscopic common bile duct exploration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Laparoscopy; Endoscopic retrograde cholangiopancreatography; Sphincterotomy; Common bile duct stones; Laparoscoopic common bile duct exploration; Cost efficiency; Examination of efficacy, safety, cost of intervention for patients with choleclithiasis and likely common bile duct stones