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

Primary Purpose

Liver Disease

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
indocyanine green fluorescent cholangiography
methylene blue
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Liver Disease focused on measuring per operative cholangiography, liver resection, biliary fistula

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amiens University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

indocyanine green fluorescent cholangiography

methylene blue

Arm Description

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

injection of methylene blue during the surgery

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 30, 2013
Last Updated
August 20, 2018
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01847612
Brief Title
Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy
Acronym
CAMFIB
Official Title
Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 8, 2013 (Actual)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease
Keywords
per operative cholangiography, liver resection, biliary fistula

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
132 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
indocyanine green fluorescent cholangiography
Arm Type
Experimental
Arm Description
use of indocyanine green fluorescent cholangiography in the patients of this arm, an indocyanine green fluorescent cholangiography is performed
Arm Title
methylene blue
Arm Type
Active Comparator
Arm Description
injection of methylene blue during the surgery
Intervention Type
Procedure
Intervention Name(s)
indocyanine green fluorescent cholangiography
Intervention Type
Drug
Intervention Name(s)
methylene blue
Primary Outcome Measure Information:
Title
biliary fistula rate
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.
Time Frame
postoperative week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jean marc regimbeau, MD, phD
Phone
+33 3 22 66 83 00
Email
regimbeau.jean-marc@chu-amiens.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Organizational Affiliation
CHU amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Amiens University Hospital
City
Amiens
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
jean marc regimbeau, MD, PhD
Phone
+33 3 22 66 83 00
Email
regimbeau.jean-marc@chu-amiens.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
23533786
Citation
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.
Results Reference
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Use of Indocyanine Green Cholangiography and Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy

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