insufficient enrollment rate
IMPACT
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
Sponsor study identifier
Secondary identifiers
interventional
35
1 country
1
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2008
Actual (reported)Study Completion
September 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
September 8, 2005
Actual (reported)September 9, 2005
Actual (reported)April 2008
Actual (reported)September 2008
Actual (reported)Factor V at day 3 after surgery
day 3
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
Perioperative Oral Nutritional Supplementation
Placebo of Perioperative Oral Nutritional Supplementation
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.
Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.
Service de Réanimation Chirurgicale - Hôpital Pontchaillou
Rennes, 35033, France
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.
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.
Yannick Mallédant, MD
Rennes University Hospital
Eric Bellissant, MD, PhD
Rennes University Hospital
Philippe Seguin, MD
Rennes University Hospital
Karim Boudjema, MD, PhD
Rennes University Hospital
35 participants (actual enrollment reported by the registry).
First Submitted
September 8, 2005
First Posted
September 9, 2005
Study Start
April 2003
Date type not reportedThis date has not been verified as actual or estimated.
T138067 Versus Doxorubicin in Chemotherapy-Naive, Unresectable, Hepatocellular Carcinoma Patients
Within 30 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
April 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
February 27, 2012
Record last verified: 2008-09
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Source: ClinicalTrials.gov.
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