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

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ClinicalTrials.gov Identifier: NCT00807729
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : September 3, 2009
Sponsor:
Information provided by:
University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 12, 2008
Last Update Posted Date September 3, 2009
Study Start Date  ICMJE January 1997
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
The primary endpoint was the efficacy of common bile duct stone clearance. [ Time Frame: Hospital admmission ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2008)
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. [ Time Frame: Hospitalization ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Trial of ERCP Then Laparoscopic Cholecystectomy vs. Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration in Patients With Likely Choledocholithiasis
Official Title  ICMJE Prospective Randomized Trial of Laparoscopic Cholecystectomy Plus Laparoscopic Common Bile Duct Exploration (LC + LCBDE) Versus Endoscopic Retrograde Cholangiopancreatography Sphincterotomy Plus Laparoscopic Cholecystectomy (ERCP/S + LC) for Common Bile Duct Stone Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Choleclithiasis
  • Common Bile Duct Stones
Intervention  ICMJE
  • Procedure: ERCP
    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
    Other Name: ERCP/ laparoscopic cholecystectomy
  • Procedure: LapCBDE
    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 Name: Laparoscopic common bile duct exploration
Study Arms  ICMJE
  • Active Comparator: ERCP
    All ERCP's were performed by one of the authors (JPC), a fulltime faculty member and gastroenterology fellowship instructor in the presence and concurrence of the principal author/ surgeon (SJR). 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. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible (i.e. following abdominal gas decompression) following the ERCP
    Intervention: Procedure: ERCP
  • Active Comparator: Lap CBDE
    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.
    Intervention: Procedure: LapCBDE
Publications * Rogers SJ, Cello JP, Horn JK, Siperstein AE, Schecter WP, Campbell AR, Mackersie RC, Rodas A, Kreuwel HT, Harris HW. Prospective randomized trial of LC+LCBDE vs ERCP/S+LC for common bile duct stone disease. Arch Surg. 2010 Jan;145(1):28-33. doi: 10.1001/archsurg.2009.226.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2008)
122
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2007
Actual Primary Completion Date July 2003   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807729
Other Study ID Numbers  ICMJE H9437-10261-12
K08DK002607 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Stanley J. Rogers, MD - Associate Professor of Surgery, UCSF, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of California, San Francisco
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP