Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.
18 Years
80 Years
Both
Patient With Hepatic Metastasis
Trial Information
Effectiveness and Tolerance of CoSeal in the Prevention of Hepatic Adherences of Novo Post Operational Within the Framework of a Hepatic Surgery of Resection in Two Times for Hepatic Metastases: Study of Phase II/III.
Inclusion Criteria:
- Major patients.
- Hepatic Carriers of metastases.
- Eligible with a procedure of surgical eradication in two brought closer times (time
lower than 3 months).
- Strategy validated in multidisciplinary meeting of cancerology.
- Enlightened Assent given and signed before the intervention.
Exclusion Criteria:
- Anaesthetic Counter-indications with a procedure in two times
- Carcinose péritonéale, reached metastatic not éradicable
- Over-sensitiveness or allergy known to polyethylene CoSeal glycol
- Concomitant Use of another antiblocking agent
- Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like
the corticosteroids,
- Impossibility of subjecting itself to the medical monitoring imposed by the study for
reasons geographical, social, psychic or medical.
- Concomitant Participation in another clinical trial
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
HEPATIC ADHERENCE SEVERITY
Outcome Description:
Measure of hepatic adherence : SCORE 0: NO HEPATIC ADHERENCE SCORE 1: SHADOW ON HEPATIC ADHERENCE SCORE 2: VASCULAR OR DENSE HEPATIC ADHERENCE SCORE 3:COHESIVE HEPATIC ADHERENCE SCORE 4: DISSECTION IN ANOTHER PLAN THIS 5 SCORE WILL BE ANALYSED ON THE 8 SEGMENT AND ON PEDICLE OF LIVER
Outcome Time Frame:
3 years
Safety Issue:
Yes
Principal Investigator
Bruno HEYD, PU-PH
Investigator Role:
Principal Investigator
Investigator Affiliation:
CHU Besançon
Authority:
France: Afssaps and ethic committee
Study ID:
P/2010/94
NCT ID:
NCT01121601
Start Date:
August 2011
Completion Date:
December 2014
Related Keywords:
- Patient With Hepatic Metastasis
- Neoplasm Metastasis
- Liver Neoplasms
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