CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion (COLIBIS)

Centre Hospitalier Universitaire de Besancon

Status and phase

Terminated

Phase 3

Phase 2

Conditions

Patient With Hepatic Metastasis

Treatments

Procedure: hepatic surgery of resection

Study type

Interventional

Funder types

Other

Identifiers

NCT01121601

P/2010/94

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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