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| ID | Type | Description | Link |
|---|---|---|---|
| PHRC/02-10 | |||
| CIC0203/012 |
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insufficient enrollment rate
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| Name | Class |
|---|---|
| Ministry of Health, France | OTHER_GOV |
| Novartis | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Perioperative Oral Nutritional Supplementation |
|
| 2 | Placebo Comparator | Placebo of Perioperative Oral Nutritional Supplementation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oral Impact® | Drug | Oral nutritional supplement containing L-arginin, ω3 polyunsaturated fatty acids, and nucleotides. Given three times a day for the 7 last preoperative and the first 3 postoperative days. |
| Measure | Description | Time Frame |
|---|---|---|
| Factor V at day 3 after surgery | day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver regeneration kinetics (bile production at days 1, 3, 5 and 7;factor V, γ-glutathione transferase, α-foetoprotein at days 1, 3, 5, 7, 10 and 30; liver volume at days 10 and 30 | days 1, 3, 5, 7, 10 and 30 | |
| Immunological biomarkers | Within 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yannick Mallédant, MD | Rennes University Hospital | Study Director |
| Eric Bellissant, MD, PhD | Rennes University Hospital | Study Chair |
| Philippe Seguin, MD | Rennes University Hospital | Principal Investigator |
| Karim Boudjema, MD, PhD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Réanimation Chirurgicale - Hôpital Pontchaillou | Rennes | 35033 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11551575 | 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. | |
| 10593328 |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| D005355 | Fibrosis |
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Placebo | Drug | Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days. |
|
| Infections | Within 30 days |
| 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. |
| 10199318 | 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. |
| D008107 |
| Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |