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

Sponsors and Collaborators:	University of California, San Francisco NIH K08DK02607
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00807729

Purpose

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.

Condition	Intervention
Choleclithiasis Common Bile Duct Stones	Procedure: ERCP Procedure: LapCBDE

MedlinePlus related topics: Endoscopy

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Glucagon Meperidine Meperidine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

The primary endpoint was the efficacy of common bile duct stone clearance. [ Time Frame: Hospital admmission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Enrollment:	122
Study Start Date:	January 1997
Study Completion Date:	November 2007
Primary Completion Date:	July 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
ERCP: Active Comparator 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	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
Lap CBDE: Active Comparator 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.	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.

Arms

Assigned Interventions

ERCP: Active Comparator

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

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

Lap CBDE: Active Comparator

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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807729

Locations

United States, California
San Francisco General Hospital
San Francisco, California, United States, 94110

Sponsors and Collaborators

University of California, San Francisco

NIH K08DK02607

More Information

Responsible Party:	University of California, San Francisco ( Stanley J. Rogers, MD - Associate Professor of Surgery, UCSF )
Study ID Numbers:	H9437-10261-12, K08DK02607
Study First Received:	December 10, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00807729
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, San Francisco:

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

Study placed in the following topic categories:

Glucagon
Midazolam
Calculi
Choledocholithiasis
Meperidine

ClinicalTrials.gov processed this record on January 16, 2009