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

NCT ID: NCT01847612

Last Updated: 2025-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-08

Study Completion Date

2025-07-03

Brief Summary

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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

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Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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indocyanine green fluorescent cholangiography

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

Group Type EXPERIMENTAL

indocyanine green fluorescent cholangiography

Intervention Type PROCEDURE

methylene blue

injection of methylene blue during the surgery

Group Type ACTIVE_COMPARATOR

methylene blue

Intervention Type DRUG

Interventions

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indocyanine green fluorescent cholangiography

Intervention Type PROCEDURE

methylene blue

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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jean marc regimbeau, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU amiens

Locations

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Amiens University Hospital

Amiens, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 23533786 (View on PubMed)

Other Identifiers

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2013-000408-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PI2013_843_0003

Identifier Type: -

Identifier Source: org_study_id

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