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Fluorescence Versus Intraoperative Cholangiography in the Visualization of Biliary Tree Anatomy

NCT01881399 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2018-03-14

No results posted yet for this study

Summary

The burden of iatrogenic bile duct injury (BDI), the most feared complication of laparoscopic cholecystectomy (LC), is extremely high and the repercussions on the patient's outcomes may be severe ranging from intraoperative repair to liver transplant or patient's death. Different techniques have been proposed to prevent BDI.

Our hypothesis is that a fluorescence-based Imaging would allow visualization of the biliary tree anatomy as good as with the Intraoperative Cholangiogram with several main advantages:

1. ease of use
2. lack of invasiveness
3. absence of ionizing radiation to the patient and the operating staff
4. performed prior to any dissection (prior to "critical view of safety")

Capacity of enhanced-reality based on virtual cholangiography (computer treatment of MRI images) to guide biliary tree anatomy visualization will be also evaluated in this study.

The study requires a 2-month patient participation.

Conditions

Interventions

DEVICE

Fluorescence cholangiography (da Vinci surgical system)

Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.

OTHER

Virtual cholangiography

Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.

PROCEDURE

Conventional IOC

Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Patrick Pessaux, Pr · Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil - Strasbourg

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • France

Study Locations

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01881399 on ClinicalTrials.gov