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

This study is currently recruiting participants.
Verified February 2013 by Centre Hospitalier Universitaire de Besancon
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT01121601
First received: May 4, 2010
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

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 Intervention Phase
Patient With Hepatic Metastasis
Procedure: hepatic surgery of resection
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Besancon:

Primary Outcome Measures:
  • HEPATIC ADHERENCE SEVERITY [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER

  • LOSS OF BLOOD [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • CoSeal tolerance [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • per operative complication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • post operative complication [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • hospitalisation time [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • operative difficulty [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    0 : no extension of hepatic adherence

    1. : 1/3 of area affected
    2. : between 1/3 and 2/3 of area affected
    3. : more than 2/3 of area affected

  • hepatic adherence reformation [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • adherence composite score [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    this is a mathematic score in relation with area and severity of liver adherence

  • composite score and surgery difficulty [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    this is a correlation between the composite score, the morbidity criteria and dissection difficulty

  • liver adherence score validation [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121601

Contacts
Contact: Bruno HEYD, PH 0381669305 ext 0033 bruno.heyd@univ-fcomte.fr

Locations
France
CHU Besançon Recruiting
Besançon, France, 25030
Contact: Pascal DEBAT, Director    0381218988 ext 0033    recherche@chu-besancon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon
Investigators
Principal Investigator: Bruno HEYD, PU-PH CHU Besançon
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT01121601     History of Changes
Other Study ID Numbers: P/2010/94
Study First Received: May 4, 2010
Last Updated: February 21, 2013
Health Authority: France: Afssaps and ethic committee

Additional relevant MeSH terms:
Neoplasm Metastasis
Liver Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 15, 2014