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

Primary Purpose

Patient With Hepatic Metastasis

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
hepatic surgery of resection
hepatic surgery of resection
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Patient With Hepatic Metastasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Besançon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group COSEAL

Reference group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2010
Last Updated
August 4, 2015
Sponsor
Centre Hospitalier Universitaire de Besancon
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1. Study Identification

Unique Protocol Identification Number
NCT01121601
Brief Title
CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
Acronym
COLIBIS
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

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Practices in surgery have evolved and the study has not interest yet
Study Start Date
August 2011 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient With Hepatic Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group COSEAL
Arm Type
Experimental
Arm Title
Reference group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
hepatic surgery of resection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
hepatic surgery of resection
Intervention Description
this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
Primary Outcome Measure Information:
Title
HEPATIC ADHERENCE SEVERITY
Description
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
Time Frame
3 years
Secondary Outcome Measure Information:
Title
LIVER RELEASE VALUE
Description
DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER
Time Frame
3 years
Title
LOSS OF BLOOD
Time Frame
3 years
Title
CoSeal tolerance
Time Frame
3 years
Title
per operative complication
Time Frame
3 years
Title
post operative complication
Time Frame
3 years
Title
hospitalisation time
Time Frame
3 years
Title
operative difficulty
Description
score 0 if there are no difficulty for the release of liver or score 10 if dissection of liver is impossible
Time Frame
3 years
Title
de novo hepatic adherence extension
Description
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
Time Frame
3 years
Title
hepatic adherence reformation
Time Frame
3 years
Title
adherence composite score
Description
this is a mathematic score in relation with area and severity of liver adherence
Time Frame
3 years
Title
composite score and surgery difficulty
Description
this is a correlation between the composite score, the morbidity criteria and dissection difficulty
Time Frame
3 years
Title
liver adherence score validation
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno HEYD, PU-PH
Organizational Affiliation
CHU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France

12. IPD Sharing Statement

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

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