Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
CAMFIB
Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study
2 other identifiers
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jul 2013
Longer than P75 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2013
CompletedFirst Posted
Study publicly available on registry
May 7, 2013
CompletedStudy Start
First participant enrolled
July 8, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 3, 2025
CompletedJuly 23, 2025
July 1, 2025
12 years
April 30, 2013
July 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
postoperative week 4
Study Arms (2)
indocyanine green fluorescent cholangiography
EXPERIMENTALuse of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed
methylene blue
ACTIVE COMPARATORinjection of methylene blue during the surgery
Interventions
Eligibility Criteria
You may qualify if:
- benin or malignant liver disease with resection of 2 or more segments
- liver resection by laparotomy
- written consent
You may not qualify if:
- previous hepatectomy
- emergency surgery
- allergy to indocyanine green
- allergy to methylene blue
- pregnancy or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Amiens University Hospital
Amiens, France
Related Publications (1)
Nguyen-Khac E, Lobry C, Chatelain D, Fuks D, Joly JP, Brevet M, Tramier B, Mouly C, Hautefeuille V, Chauffert B, Regimbeau JM. A Reappraisal of Chemotherapy-Induced Liver Injury in Colorectal Liver Metastases before the Era of Antiangiogenics. Int J Hepatol. 2013;2013:314868. doi: 10.1155/2013/314868. Epub 2013 Mar 7.
PMID: 23533786BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
jean marc regimbeau, MD, PhD
CHU amiens
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2013
First Posted
May 7, 2013
Study Start
July 8, 2013
Primary Completion
July 3, 2025
Study Completion
July 3, 2025
Last Updated
July 23, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share