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

NCT00807729 | Completed

• 2 other identifiers: H9437-10261-12K08DK002607
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

Choleclithiasis; Common Bile Duct Stones

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

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the efficacy of common bile duct stone clearance.

  Hospital admmission

Secondary Outcomes (1)

• 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

Study Arms (2)

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

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

Interventions

ERCP PROCEDURE

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

Also known as: ERCP/ laparoscopic cholecystectomy

ERCP

LapCBDE PROCEDURE

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.

Also known as: Laparoscopic common bile duct exploration

Lap CBDE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Common bile duct diameter greater than 6 mm by ultrasound or computed tomography (CT) scan
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

San Francisco General Hospital

San Francisco, California, 94110, United States

Location

Related Publications (1)

• 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.

  PMID: 20083751 DERIVED

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde; Cholecystectomy, Laparoscopic

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cholecystectomy; Biliary Tract Surgical Procedures; Laparoscopy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 10, 2008
• First Posted: December 12, 2008
• Study Start: January 1, 1997
• Primary Completion: July 1, 2003
• Study Completion: November 1, 2007
• Last Updated: September 3, 2009

Record last verified: 2009-09

Locations

US (1)