CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
Conditions
Patient With Hepatic Metastasis
Conditions: official terms
Liver Neoplasms - Neoplasm Metastasis
Study Type
Interventional
Study Phase
Phase 2/Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Intervention
Name: hepatic surgery of resection Type: Procedure
Name: hepatic surgery of resection Type: Procedure
Overall Status
Recruiting
Summary
Study of phase II: Clinical study national, exploratory, multicentric, prospective, randomized, as a double blind man evaluating the effectiveness and the tolerance of the treatment by a surgical gel of sealing containing polyethylene glycol in the prevention of operational adherences post.3 Study of phase III: Clinical study national, multicentric, prospective, randomized, controlled, as a double blind man comparing a group controls with a group of patients treated by a surgical gel of sealing containing polyethylene glycol in the prevention of hepatic adherences of novo post operational.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Both
Criteria: 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
Location
CHU Besançon
Besançon, France
Status: Recruiting
Contact: Pascal DEBAT, Director - 0381218988 - recherche@chu-besancon.fr
Start Date
August 2011
Completion Date
December 2014
Sponsors
Centre Hospitalier Universitaire de Besancon
Source
Centre Hospitalier Universitaire de Besancon
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page