Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
Phase 3
- Conditions
- Liver Disease
- Interventions
- Procedure: indocyanine green fluorescent cholangiography
- Registration Number
- NCT01847612
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 132
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description indocyanine green fluorescent cholangiography indocyanine green fluorescent cholangiography use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed methylene blue methylene blue injection of methylene blue during the surgery
- Primary Outcome Measures
Name Time Method biliary fistula rate 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Amiens University Hospital
🇫🇷Amiens, France