COLIBIS: CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group COSEAL
|
Procedure: 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.
|
| Active Comparator: Reference group
|
Procedure: hepatic surgery of resection
this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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]
- post operative complication [3 years]
- hospitalisation time [3 years]
- 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
- de novo hepatic adherence extension [3 years]
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
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Major patients.
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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:
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Anaesthetic Counter-indications with a procedure in two times
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Carcinose péritonéale, reached metastatic not éradicable
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Over-sensitiveness or allergy known to polyethylene CoSeal glycol
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Concomitant Use of another antiblocking agent
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Immunodéprimés Patients or taking drugs immunodépresseurs with the long court like the corticosteroids,
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Besançon | Besançon | France | 25030 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
- Principal Investigator: Bruno HEYD, PU-PH, CHU Besançon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P/2010/94