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

Centre Hospitalier Universitaire, Amiens150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

150

Conditions

Liver Disease

Interventions

indocyanine green fluorescent cholangiographyPROCEDURE

methylene blueDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Amiens University Hospital

Amiens, France

Outcomes

Primary Outcomes

biliary fistula rate

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.

Time frame: postoperative week 4

Data from ClinicalTrials.gov

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