Patient With Hepatic Metastasis Clinical Trial
— COLIBISOfficial title:
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.
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.
| Status | Terminated |
| Enrollment | 29 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Besançon | Besançon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire de Besancon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | HEPATIC ADHERENCE SEVERITY | 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 |
3 years | Yes |
| Secondary | LIVER RELEASE VALUE | DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER | 3 years | No |
| Secondary | LOSS OF BLOOD | 3 years | Yes | |
| Secondary | CoSeal tolerance | 3 years | Yes | |
| Secondary | per operative complication | 3 years | Yes | |
| Secondary | post operative complication | 3 years | Yes | |
| Secondary | hospitalisation time | 3 years | Yes | |
| Secondary | operative difficulty | score 0 if there are no difficulty for the release of liver or score 10 if dissection of liver is impossible | 3 years | No |
| Secondary | de novo hepatic adherence extension | 0 : no extension of hepatic adherence : 1/3 of area affected : between 1/3 and 2/3 of area affected : more than 2/3 of area affected |
3 years | No |
| Secondary | hepatic adherence reformation | 3 years | No | |
| Secondary | adherence composite score | this is a mathematic score in relation with area and severity of liver adherence | 3 years | No |
| Secondary | composite score and surgery difficulty | this is a correlation between the composite score, the morbidity criteria and dissection difficulty | 3 years | Yes |
| Secondary | liver adherence score validation | 3 years | No |