CAMFIB: Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Unknown status

CT.gov ID

NCT01847612

Collaborator

(none)

132

Enrollment

Location

Arms

60.8

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the present study is to evaluate whether the use of indocyanine green fluorescent cholangiography is responsible in a decrease of biliary fistula's rate in patients with liver diseases requiring liver resection.

Condition or Disease	Intervention/Treatment	Phase
Liver Disease	Procedure: indocyanine green fluorescent cholangiography Drug: methylene blue	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

132 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study

Actual Study Start Date :

Jul 8, 2013

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: indocyanine green fluorescent cholangiography use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed	Procedure: indocyanine green fluorescent cholangiography
Active Comparator: methylene blue injection of methylene blue during the surgery	Drug: methylene blue

Arm

Intervention/Treatment

Experimental: indocyanine green fluorescent cholangiography

use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed

Procedure: indocyanine green fluorescent cholangiography

Active Comparator: methylene blue

injection of methylene blue during the surgery

Drug: methylene blue

Outcome Measures

Primary Outcome Measures

biliary fistula rate [postoperative week 4]
the biliary fistula is defined as a bilirubin in the drain three times higher than the serum bilirubin. the primary endpoint will be evaluated by a medical committee composed by investigators not involved in the patients enrollment.