NCT00416234

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

January 14, 2010

Status Verified

June 1, 2008

Enrollment Period

4.3 years

First QC Date

December 26, 2006

Last Update Submit

January 13, 2010

Conditions

CholedocholithiasisCholelithiasis

Outcome Measures

Primary Outcomes (1)

  • postoperative hospital stay

    from onset of intervention to discharge

Secondary Outcomes (8)

  • success rate of CBD clearance

    during ERCP

  • failure rate of selective CBD cannulation

    during ERCP

  • incidence of multiple endoscopic procedures

    within 30 days

  • incidence of hyperamylasemia

    within 48 hours post-ERCP

  • incidence of severe pancreatitis (APACHE II score >6)

    within 48 hours post-ERCP

  • +3 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: Laparoendoscopic Rendez vous

2

ACTIVE COMPARATOR

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

Procedure: preoperative ERCP and CBD clearance

Interventions

Laparoendoscopic Rendez vousPROCEDURE

intraoperative ERCP for CBD clearance during laparoscopic cholecystectomy

1
preoperative ERCP and CBD clearancePROCEDURE

ERCP and CBD clearance followed by laparoscopic cholecystectomy

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • patients not fit for surgery (ASA IV)
  • previous ERCP and sphincterotomy
  • previous upper abdominal surgery
  • pregnancy at time of surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Larissa

Larissa, Thessaly, 413 35, Greece

RECRUITING

Related Publications (1)

  • 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.

    PMID: 22261836DERIVED

MeSH Terms

Conditions

CholedocholithiasisCholelithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System Diseases

Study Officials

  • Constantine Hatzitheofilou, MD

    University of Thessaly, School of Medicine

    STUDY CHAIR

  • George Tzovaras, MD

    University of Thessaly, School of Medicine

    STUDY DIRECTOR

  • Ioannis Baloyiannis, MD

    University Hospital of Larissa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Tzovaras, MD

CONTACT

+30 2410 682730gtzovaras@hotmail.com

Ioannis Baloyiannis, MD

CONTACT

+30 2410 682728balioan@hotmail.com

Study Design

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

Study Record Dates

First Submitted

December 26, 2006

First Posted

December 27, 2006

Study Start

September 1, 2006

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

January 14, 2010

Record last verified: 2008-06

Locations

GR(1)