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

• 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 ]

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.

• 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

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