Patient With Hepatic Metastasis
Conditions
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.
Interventions
PROCEDUREhepatic 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.
Sponsors
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HEPATIC ADHERENCE SEVERITY | 3 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| operative difficulty | 3 years | score 0 if there are no difficulty for the release of liver or score 10 if dissection of liver is impossible |
| LIVER RELEASE VALUE | 3 years | DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER |
| LOSS OF BLOOD | 3 years | — |
| CoSeal tolerance | 3 years | — |
| per operative complication | 3 years | — |
| hospitalisation time | 3 years | — |
| de novo hepatic adherence extension | 3 years | 0 : no extension of hepatic adherence 1. : 1/3 of area affected 2. : between 1/3 and 2/3 of area affected 3. : more than 2/3 of area affected |
| hepatic adherence reformation | 3 years | — |
| adherence composite score | 3 years | this is a mathematic score in relation with area and severity of liver adherence |
| composite score and surgery difficulty | 3 years | this is a correlation between the composite score, the morbidity criteria and dissection difficulty |
| liver adherence score validation | 3 years | — |
| post operative complication | 3 years | — |
Countries
France
Outcome results
None listed