Clinical trial NCT01121601: CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Patient With Hepatic Metastasis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2010-05-12
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: HEPATIC ADHERENCE SEVERITY
timeFrame: 3 years
Secondary outcomes:
measure: LIVER RELEASE VALUE
timeFrame: 3 years
measure: LOSS OF BLOOD
timeFrame: 3 years
measure: CoSeal tolerance
timeFrame: 3 years
measure: per operative complication
timeFrame: 3 years
measure: post operative complication
timeFrame: 3 years
measure: hospitalisation time
timeFrame: 3 years
measure: operative difficulty
timeFrame: 3 years
measure: de novo hepatic adherence extension
timeFrame: 3 years
measure: hepatic adherence reformation
timeFrame: 3 years
measure: adherence composite score
timeFrame: 3 years
measure: composite score and surgery difficulty
timeFrame: 3 years
measure: liver adherence score validation
timeFrame: 3 years
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Bruno HEYD, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: