drugset / Trial / NCT00151671
Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer
Phase 2/3
Terminated
35 enrolled
Rennes University Hospital
Ministry of Health, France · collabNovartis · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Cirrhotic patients undergoing hepatic resection have a mortality rate near 10%, and 30 to 70% of them develop severe complications. These failures are mainly due to hepatic insufficiency. Studies have already shown benefits of oral nutritional supplements in ORL, digestive, and cardiac surgery. We aimed to ascertain whether this nutritional, immune-enhancing supplementation, administered 7 days before and 3 days after surgery, could improve liver function and postoperative host defences in patients with liver cancer resection.
Timeline
- Start
- 2003-04
- Primary completion
- 2008-04
- Completion
- 2008-09
Outcome
Outcome not reported
Stopped (Enrollment): “insufficient enrollment rate”
Publications
- Background Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701. doi: 10.1016/s0140-6736(01)05836-6.
- Background Senkal M, Zumtobel V, Bauer KH, Marpe B, Wolfram G, Frei A, Eickhoff U, Kemen M. Outcome and cost-effectiveness of perioperative enteral immunonutrition in patients undergoing elective upper gastrointestinal tract surgery: a prospective randomized study. Arch Surg. 1999 Dec;134(12):1309-16. doi: 10.1001/archsurg.134.12.1309.
- Background Braga M, Gianotti L, Radaelli G, Vignali A, Mari G, Gentilini O, Di Carlo V. Perioperative immunonutrition in patients undergoing cancer surgery: results of a randomized double-blind phase 3 trial. Arch Surg. 1999 Apr;134(4):428-33. doi: 10.1001/archsurg.134.4.428.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Oral Impact® | Other / unclassified | — | Oral |