Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer (IMPACT)
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.
Drug: Oral Impact®
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Factor V at day 3 after surgery [ Time Frame: day 3 ] [ Designated as safety issue: No ]
- 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 [ Time Frame: days 1, 3, 5, 7, 10 and 30 ] [ Designated as safety issue: No ]
- Immunological biomarkers [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
- Infections [ Time Frame: Within 30 days ] [ Designated as safety issue: No ]
|Study Start Date:||April 2003|
|Study Completion Date:||September 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Perioperative Oral Nutritional Supplementation
Drug: Oral Impact®
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.
Placebo Comparator: 2
Placebo of Perioperative Oral Nutritional Supplementation
Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151671
|Service de Réanimation Chirurgicale - Hôpital Pontchaillou|
|Rennes, France, 35033|
|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|