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

Liver Disease Clinical Trial

— CAMFIB  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01847612
• Other study ID #: PI2013_843_0003
• Secondary ID: 2013-000408-40
• Status: Recruiting
• Phase: Phase 3
• Start date: July 8, 2013
• Est. completion date: August 2018

Study information

• Verified date: August 2018
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: jean marc regimbeau, MD, phD
• Phone: +33 3 22 66 83 00
• Email: regimbeau.jean-marc[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: August 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Fistula
• Fistula
• Liver Disease
• Liver Diseases

Intervention

Procedure:
• indocyanine green fluorescent cholangiography

Drug:
• methylene blue

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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