Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Liver Neoplasms
Neoplasm Metastasis
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms
Neoplasms by Site
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on November 19, 2014