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

Study Overview
=================
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.

Official 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.

Conditions
-----------------
Patient With Hepatic Metastasis

Intervention / Treatment
-----------------
* Procedure: hepatic surgery of resection
* Procedure: hepatic surgery of resection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group COSEAL<br> | Procedure: hepatic surgery of resection<br>* 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.<br>|
| Active Comparator: Reference group<br> | Procedure: hepatic surgery of resection<br>* this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LIVER RELEASE VALUE | DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER | 3 years | 
| LOSS OF BLOOD |  | 3 years | 
| CoSeal tolerance |  | 3 years | 
| per operative complication |  | 3 years | 
| post operative complication |  | 3 years | 
| hospitalisation time |  | 3 years | 
| 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 | 
| 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 | 
| hepatic adherence reformation |  | 3 years | 
| adherence composite score | this is a mathematic score in relation with area and severity of liver adherence | 3 years | 
| composite score and surgery difficulty | this is a correlation between the composite score, the morbidity criteria and dissection difficulty | 3 years | 
| liver adherence score validation |  | 3 years |