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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01847612
Acronym
CAMFIB
Enrollment
150
Registered
2013-05-07
Start date
2013-07-08
Completion date
2025-07-03
Last updated
2025-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

Keywords

per operative cholangiography, liver resection, biliary fistula

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.

Interventions

PROCEDUREindocyanine green fluorescent cholangiography
DRUGmethylene blue

Sponsors

Centre Hospitalier Universitaire, Amiens
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
biliary fistula ratepostoperative week 4the 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026