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

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.

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Key information

Conditions

Liver Disease Biliary Fistula Digestive System Diseases Digestive System Fistula Fistula Liver Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amiens University Hospital

Amiens, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

indocyanine green fluorescent cholangiography

Procedure

Methylene Blue

Drug

Primary outcomes

biliary fistula rate

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: CAMFIB

Important dates

Study start: 2013
Primary completion: 2025
Study completion: 2025
First posted: May 7, 2013
Registry last updated: Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed