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

Primary Purpose

Choledocholithiasis, Cholelithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Laparoendoscopic Rendez vous
preoperative ERCP and CBD clearance
Sponsored by
University of Thessaly
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choledocholithiasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of LarissaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

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

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

Outcomes

Primary Outcome Measures

postoperative hospital stay

Secondary Outcome Measures

success rate of CBD clearance
failure rate of selective CBD cannulation
incidence of multiple endoscopic procedures
incidence of hyperamylasemia
incidence of severe pancreatitis (APACHE II score >6)
total hospital stay
complications other but pancreatitis
death

Full Information

First Posted
December 26, 2006
Last Updated
January 13, 2010
Sponsor
University of Thessaly
Collaborators
Larissa University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00416234
Brief Title
Laparoendoscopic Rendez Vous Versus Standard Two Stage Approach for the Management of Cholelithiasis/Choledocholithiasis
Official Title
Laparoendoscopic Rendez Vous (Intraoperative ERCP) vs Two Stage Approach (Preoperative ERCP Followed by Laparoscopic Cholecystectomy) for the Management of Cholelithiasis/Choledocholithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Thessaly
Collaborators
Larissa University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choledocholithiasis, Cholelithiasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Laparoendoscopic Rendez vous (one stage management of cholelithiasis/choledocholithiasis)
Arm Title
2
Arm Type
Active Comparator
Arm Description
preoperative ERCP and CBD clearance followed by lap cholecystectomy (two stage management of cholelithiasis/choledocholithiasis)
Intervention Type
Procedure
Intervention Name(s)
Laparoendoscopic Rendez vous
Intervention Description
intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
preoperative ERCP and CBD clearance
Intervention Description
ERCP and CBD clearance followed by laparoscopic cholecystectomy
Primary Outcome Measure Information:
Title
postoperative hospital stay
Time Frame
from onset of intervention to discharge
Secondary Outcome Measure Information:
Title
success rate of CBD clearance
Time Frame
during ERCP
Title
failure rate of selective CBD cannulation
Time Frame
during ERCP
Title
incidence of multiple endoscopic procedures
Time Frame
within 30 days
Title
incidence of hyperamylasemia
Time Frame
within 48 hours post-ERCP
Title
incidence of severe pancreatitis (APACHE II score >6)
Time Frame
within 48 hours post-ERCP
Title
total hospital stay
Time Frame
from admission to discharge
Title
complications other but pancreatitis
Time Frame
within 30 days
Title
death
Time Frame
within 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
George Tzovaras, MD
Phone
+30 2410 682730
Email
gtzovaras@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ioannis Baloyiannis, MD
Phone
+30 2410 682728
Email
balioan@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Constantine Hatzitheofilou, MD
Organizational Affiliation
University of Thessaly, School of Medicine
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
George Tzovaras, MD
Organizational Affiliation
University of Thessaly, School of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ioannis Baloyiannis, MD
Organizational Affiliation
University Hospital of Larissa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Larissa
City
Larissa
State/Province
Thessaly
ZIP/Postal Code
413 35
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Tzovaras, MD
Phone
+30 2410 682730
Email
gtzovaras@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ioannis Baloyiannis, MD
First Name & Middle Initial & Last Name & Degree
Spyros Potamianos, MD
First Name & Middle Initial & Last Name & Degree
George Paroutoglou, MD
First Name & Middle Initial & Last Name & Degree
Georgia Stamatiou, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
22261836
Citation
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.
Results Reference
derived

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

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