CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion (COLIBIS)

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.

Study Overview

• Status: Terminated
• Conditions: Patient With Hepatic Metastasis
• Intervention / Treatment: Procedure: hepatic surgery of resection; Procedure: hepatic surgery of resection

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHU Besançon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.; Procedure: hepatic surgery of resection; this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
ACTIVE_COMPARATOR: Reference group	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.; Procedure: hepatic surgery of resection; this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Investigators: Principal Investigator: Bruno HEYD, PU-PH, CHU Besançon

Study record dates

Study Major Dates

• Study Start: August 1, 2011

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: May 10, 2010
• First Posted (ESTIMATE): May 12, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2015
• Last Update Submitted That Met QC Criteria: August 4, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis
• Other Study ID Numbers: P/2010/94