Effect of a Perioperative Oral Nutritional Supplementation on Patients Undergoing Hepatic Surgery for Liver Cancer (IMPACT)
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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® Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 35 |
| Study Start Date: | April 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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
|
Drug: Placebo
Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
|
Detailed Description:
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:
- 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
Contacts and Locations| France | |
| 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 |
More Information
Publications:
| Responsible Party: | Direction of Clinical Research and Strategy, Rennes University Hospital |
| ClinicalTrials.gov Identifier: | NCT00151671 History of Changes |
| Other Study ID Numbers: | AFSSAPS 21541, PHRC/02-10, CIC0203/012 |
| Study First Received: | September 8, 2005 |
| Last Updated: | February 24, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Rennes University Hospital:
|
Surgery Liver Cancer Cirrhosis Nutrition |
Additional relevant MeSH terms:
|
Carcinoma Fibrosis Liver Cirrhosis Liver Neoplasms Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms Pathologic Processes Liver Diseases Digestive System Diseases Digestive System Neoplasms Neoplasms by Site Adenocarcinoma |
ClinicalTrials.gov processed this record on October 16, 2012
