CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion

NCT ID: NCT01121601

Last Updated: 2015-08-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31

Brief 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.

Conditions

Patient With Hepatic Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group COSEAL

Group Type: EXPERIMENTAL

hepatic surgery of resection

Intervention Type: PROCEDURE

after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.

Reference group

Group Type: ACTIVE_COMPARATOR

hepatic surgery of resection

Intervention Type: PROCEDURE

this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group

Interventions

hepatic surgery of resection

after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.

Intervention Type: PROCEDURE

hepatic surgery of resection

this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Besancon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno HEYD, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHU Besançon

Locations

CHU Besançon

Besançon, France, France

Countries

France

Other Identifiers

P/2010/94

Identifier Type: -

Identifier Source: org_study_id