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| Sponsors and Collaborators: |
Rennes University Hospital Ministry of Health, France Novartis |
| Information provided by: | Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00151671 |
Purpose
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.
| Condition | Intervention | Phase |
|
Liver Cancer Hepatocellular Carcinoma Cirrhosis Liver Fibrosis |
Drug: Oral Impact® |
Phase II Phase III |
| MedlinePlus related topics: | Cancer Cirrhosis Dietary Supplements Liver Cancer |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Prospective, Randomized, Double Blind, Placebo-Controlled Study Evaluating the Effect of Oral Immune-Enhancing Nutritional Supplement on Hepatic Function After Liver Resection for Primary or Secondary Cancer on Cirrhosis or Liver Fibrosis |
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2003 |
In patients undergoing hepatic resection for liver cancer (with cirrhosis or fibrosis liver), mortality rate can reach 10% and morbidity (ascites, icteria, infections) 70%. These complications are mainly due to hepatic insufficiency: surgery leaves a reduced parenchyma, with oxidative stress lesions due to reperfusion injury. A good preoperative nutritional state has been shown to reduce complications and mortality. This can be amplified by preoperative nutrition with supplements containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides which boost immune responses, resistance to infections and liver function recovery. In this context, the study randomly assigns 50 patients who were scheduled to undergo hepatic resection, to receive either an oral immune-enhancing nutritional supplement or a placebo, for the 7 last preoperative and the first 3 postoperative days. The aim of the study is to evaluate the effects of this supplementation on liver function, immunity, and incidence of infections after surgery.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yannick Mallédant, MD | 33-2-9928-4246 | yannick.malledant@chu-rennes.fr |
| Contact: Eric Bellissant, MD, PhD | 33-2-9928-9200 | eric.bellissant@chu-rennes.fr |
| France | |||||
| Service de Réanimation Chirurgicale - Hôpital Pontchaillou | Recruiting | ||||
| Rennes, France, 35033 | |||||
| Contact: Yannick Mallédant, MD 33-2-9928-4246 yannick.malledant@chu-rennes.fr | |||||
| Principal Investigator: Philippe Seguin, MD | |||||
| Principal Investigator: Karim Boudjema, MD, PhD | |||||
| Sub-Investigator: Yves Gandon, MD | |||||
| Sub-Investigator: Gilbert Semana, MD | |||||
| Rennes University Hospital |
| Ministry of Health, France |
| Novartis |
| Study Director: | Yannick Mallédant, MD | Rennes University Hospital |
| Study Chair: | Eric Bellissant, MD, PhD | Rennes University Hospital |
| Principal Investigator: | Philippe Seguin, MD | Rennes University Hospital |
| Principal Investigator: | Karim Boudjema, MD, PhD | Rennes University Hospital |
More Information
| Study ID Numbers: | AFSSAPS 21541, PHRC/02-10, CIC0203/012 |
| First Received: | September 8, 2005 |
| Last Updated: | May 7, 2007 |
| ClinicalTrials.gov Identifier: | NCT00151671 |
| Health Authority: | France: Afssaps - French Health Products Safety Agency |
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