NCT00151671

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2003

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 27, 2012

Status Verified

September 1, 2008

Enrollment Period

5 years

First QC Date

September 8, 2005

Last Update Submit

February 24, 2012

Conditions

Liver CancerHepatocellular CarcinomaCirrhosisLiver Fibrosis

Keywords

SurgeryLiver CancerCirrhosisNutrition

Outcome Measures

Primary Outcomes (1)

  • Factor V at day 3 after surgery

    day 3

Secondary Outcomes (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

    Within 30 days

Study Arms (2)

1

EXPERIMENTAL

Perioperative Oral Nutritional Supplementation

Drug: Oral Impact®

2

PLACEBO COMPARATOR

Placebo of Perioperative Oral Nutritional Supplementation

Drug: Placebo

Interventions

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.

1
PlaceboDRUG

Oral solution of placebo. Given three times a day for the 7 last preoperative and the first 3 postoperative days.

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Recent weight loss of more than 10% of body weight
  • Immunological deficiency
  • Portal or hepatic arterial thrombosis
  • Biliary duct dilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Réanimation Chirurgicale - Hôpital Pontchaillou

Rennes, 35033, France

Location

Related Publications (3)

  • 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.

    PMID: 11551575BACKGROUND

  • 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.

    PMID: 10593328BACKGROUND

  • 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.

    PMID: 10199318BACKGROUND

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, HepatocellularFibrosisLiver Cirrhosis

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

April 1, 2003

Primary Completion

April 1, 2008

Study Completion

September 1, 2008

Last Updated

February 27, 2012

Record last verified: 2008-09

Locations

FR(1)