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Trial · Interventional

CompletedPhase 3Registry data

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

Short name CAMFIB

NCTNCT01847612 (opens ClinicalTrials.gov in a new tab)Other idPI2013_843_0003Other id2013-000408-40
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
150 participants (actual)
Sponsor
Centre Hospitalier Universitaire, Amiens · Other
Design
Randomized · Single masking
Countries
1 country

France

Start
8 Jul 2013
Primary completion
3 Jul 2025
Completion
3 Jul 2025
First posted
7 May 2013 (estimated)
Last update posted
23 Jul 2025
Conditions
Liver Disease

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201520202025
  1. Ph 3

    CAMFIB

    NCT01847612

    8 Jul 2013 to 3 Jul 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • indocyanine green fluorescent cholangiographyProcedure
  • methylene blueDrug

Arms2

  • Experimental

    indocyanine green fluorescent cholangiography

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

  • Active comparator

    methylene blue

    injection of methylene blue during the surgery

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. biliary fistula rate

    Time frame · postoperative week 4

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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