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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00416234
Other study ID # Larissa CBD stones trial
Secondary ID
Status Recruiting
Phase N/A
First received December 26, 2006
Last updated January 13, 2010
Start date September 2006
Est. completion date December 2010

Study information

Verified date June 2008
Source University of Thessaly
Contact George Tzovaras, MD
Phone +30 2410 682730
Email gtzovaras@hotmail.com
Is FDA regulated No
Health authority Greece: Ministry of Health and Welfare
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.


Description:

The ideal management of concomitant cholelithiasis and choledocholithiasis is not known yet. There are several options, including one-stage or two-stage approaches. The most commonly used practice is the two-stage management which consists of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy. However, with this approach, a number of patients will be submitted to an unnecessary ERCP while some others will develop complications, mainly pancreatitis due to inadvertent pancreatic duct cannulation. Laparo-endoscopic rendez-vous methods have been described in order to obtain selective CBD cannulation and omit the risk of post-ERCP pancreatitis. In this procedure, during laparoscopic cholecystectomy, a wire is inserted through the cystic duct into the common bile duct, advanced into the duodenum where is found endoscopically, gripped with a snare and retrieved through the mouth. The a sphincterotome is inserted over the wire and elective CBD cannulation is obtained to be followed by sphincterotomy and CBD clearance intraoperatively. The method has been described by several authors in small to moderate case series, its safety has been proven and it appears that reduces both the length of hospital stay and the incidence of post-ERCP pancreatitis.However, it has not been popularized and has never been tested over the standard two-stage management. In our hospital, the standard approach for cholelithiasis and choledocholithiasis has been, as well, the two-stage (preop ERCP and sphincterotomy followed by laparoscopic cholecystectomy)approach. We initially assessed the feasibility and safety of the laparo-endoscopic rendez vous with a pilot study and now we intend to compare the two methods in a prospective randomized trial.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients must be able to give informed consent preoperatively

- ASA I-III

- patients at high risk to have CBD stones (jaundice, cholangitis, grossly deranged LFTs, CBD stones found on US or MRCP)

Exclusion Criteria:

- patients not fit for surgery (ASA IV)

- previous ERCP and sphincterotomy

- previous upper abdominal surgery

- pregnancy at time of surgery

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Laparoendoscopic Rendez vous
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
preoperative ERCP and CBD clearance
ERCP and CBD clearance followed by laparoscopic cholecystectomy

Locations

Country Name City State
Greece University Hospital of Larissa Larissa Thessaly

Sponsors (2)

Lead Sponsor Collaborator
University of Thessaly Larissa University Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative hospital stay from onset of intervention to discharge No
Secondary success rate of CBD clearance during ERCP Yes
Secondary failure rate of selective CBD cannulation during ERCP Yes
Secondary incidence of multiple endoscopic procedures within 30 days Yes
Secondary incidence of hyperamylasemia within 48 hours post-ERCP Yes
Secondary incidence of severe pancreatitis (APACHE II score >6) within 48 hours post-ERCP Yes
Secondary total hospital stay from admission to discharge No
Secondary complications other but pancreatitis within 30 days Yes
Secondary death within 30 days Yes
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