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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Liver Disease

Treatments: Procedure: indocyanine green fluorescent cholangiography; Drug: methylene blue

Study type: Interventional

Funder types: Other

Identifiers

NCT01847612

2013-000408-40 (EudraCT Number)

PI2013_843_0003

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• benin or malignant liver disease with resection of 2 or more segments
• liver resection by laparotomy
• written consent

Exclusion criteria

• previous hepatectomy
• emergency surgery
• allergy to indocyanine green
• allergy to methylene blue
• pregnancy or breastfeeding

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

indocyanine green fluorescent cholangiography

Experimental group

Description:

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

Treatment:

Procedure: indocyanine green fluorescent cholangiography

methylene blue

Active Comparator group

Description:

injection of methylene blue during the surgery

Treatment:

Drug: methylene blue