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Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis

NCT ID: NCT00416234

Last Updated: 2010-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Choledocholithiasis Cholelithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)

Group Type ACTIVE_COMPARATOR

Laparoendoscopic Rendez vous

Intervention Type PROCEDURE

intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy

2

preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis)

Group Type ACTIVE_COMPARATOR

preoperative ERCP and CBD clearance

Intervention Type PROCEDURE

ERCP and CBD clearance followed by laparoscopic cholecystectomy

Interventions

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Laparoendoscopic Rendez vous

intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy

Intervention Type PROCEDURE

preoperative ERCP and CBD clearance

ERCP and CBD clearance followed by laparoscopic cholecystectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Larissa University Hospital

OTHER

Sponsor Role collaborator

University of Thessaly

OTHER

Sponsor Role lead

Responsible Party

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University of Thessaly, School of Medicine

Principal Investigators

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Constantine Hatzitheofilou, MD

Role: STUDY_CHAIR

University of Thessaly, School of Medicine

George Tzovaras, MD

Role: STUDY_DIRECTOR

University of Thessaly, School of Medicine

Ioannis Baloyiannis, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Larissa

Locations

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University Hospital of Larissa

Larissa, Thessaly, Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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George Tzovaras, MD

Role: CONTACT

[email protected]
+30 2410 682730

Ioannis Baloyiannis, MD

Role: CONTACT

[email protected]
+30 2410 682728

Facility Contacts

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George Tzovaras, MD

Role: primary

[email protected]
+30 2410 682730

References

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Tzovaras G, Baloyiannis I, Zachari E, Symeonidis D, Zacharoulis D, Kapsoritakis A, Paroutoglou G, Potamianos S. Laparoendoscopic rendezvous versus preoperative ERCP and laparoscopic cholecystectomy for the management of cholecysto-choledocholithiasis: interim analysis of a controlled randomized trial. Ann Surg. 2012 Mar;255(3):435-9. doi: 10.1097/SLA.0b013e3182456ec0.

Reference Type DERIVED
PMID: 22261836 (View on PubMed)

Other Identifiers

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Larissa CBD stones trial

Identifier Type: -

Identifier Source: org_study_id

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