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

May 4, 2010
February 21, 2013
August 2011
May 2014   (final data collection date for primary outcome measure)
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

Same as current
Complete list of historical versions of study NCT01121601 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
CoSeal in Liver and Biliary Surgery in Prevention of Denovo Hepatic Adhesion
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Patient With Hepatic Metastasis
  • 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
  • Experimental: Group COSEAL
    Intervention: Procedure: hepatic surgery of resection
  • Active Comparator: Reference group
    Intervention: Procedure: hepatic surgery of resection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact: Bruno HEYD, PH 0381669305 ext 0033 bruno.heyd@univ-fcomte.fr
France
 
NCT01121601
P/2010/94
Yes
Centre Hospitalier Universitaire de Besancon
Centre Hospitalier Universitaire de Besancon
Not Provided
Principal Investigator: Bruno HEYD, PU-PH CHU Besançon
Centre Hospitalier Universitaire de Besancon
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP