Sponsor investigator | Prof. Pierre-Alain Clavien, MD PhD |
---|---|
Study product | Omegaven™, 100 ml intravenously administered at the evening before and during liver resection |
Primary endpoint | Postoperative morbidity and mortality determined by the Clavien- Dindo classification of surgical complications and the Comperative Complication Index (CCI) 1 month after hospital discharge. |
Secondary endpoints | Main center: |
Serum samples: postoperative peak AST and ALT, fatty acids and n3 PUVA concentration, inflammatory markers | |
Liver biopsy: histology (necrosis, apoptosis), inflammatory markers, hepatic fatty acid and n3 PUVA content | |
Main center and external centers: | |
Duration of hospitalization and ICU stay | |
Hematology: hemoglobin, hematocrit, leukocytes, platelets, INR | |
Chemistry: triglycerides, bilirubin, AST, ALT, ALKP, creatinin, CRP | |
Methodology | Randomized, double-blind, placebo controlled |
Clinical phase | Phase III (new indication for Omegaven™) |
Study duration | 3 years (start: July 2013) |
Study centers | Multi-center (Zurich, Bucharest, Moscow) |
Number of subjects | 258 patients |
Main inclusion criteria | Adult (more than 18 years) requiring liver resection of at least 1 segment or multiple wedge resections (≥3); no coagulopathy (INR ≤ 1.2, platelets ≥ 150,000 × 103/μl) |
Main exclusion criteria | Liver resections <1 segment, wedge resections (<3); coagulopathy (INR > 1.2, platelets < 150,000 × 103/μl); hypertriglyceridemia (>5.0 mmol/l); liver cirrhosis; severe renal failure (estimated GFR < 30 ml/min/1.73 m2); pregnancy. |
ClinicalTrial.gov | ID: NCT01884948 |