Liver Disease Clinical Trial
— CAMFIBOfficial title:
Evaluation of Indocyanine Green Fluorescent Cholangiography Versus Methylene Blue to Detect Postoperative Biliary Fistula After Hepatectomy: Randomized Controlled Study
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Amiens University Hospital | Amiens |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire, Amiens |
France,
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
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 |
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