Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Liver Cancer, Hepatocellular Carcinoma, Cirrhosis, Liver Fibrosis

Intervention / Treatment
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* Drug: Oral Impact®
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult over 18 years Hepatectomy of at least 2 segments For primary or secondary cancer With cirrhosis (Child Pugh <8) or liver fibrosis (fibrosis score of 3) Informed written consent Exclusion Criteria: Pregnancy Recent weight loss of more than 10% of body weight Immunological deficiency Portal or hepatic arterial thrombosis Biliary duct dilation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Perioperative Oral Nutritional Supplementation | Drug: Oral Impact®<br>* 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.<br>|
| Placebo Comparator: 2<br>Placebo of Perioperative Oral Nutritional Supplementation | Drug: Placebo<br>* Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factor V at day 3 after surgery |  | day 3 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Infections |  | Within 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Liver Cancer, Cirrhosis, Nutrition