A Phase 2/3 interventional study of hepatic surgery of resection and hepatic surgery of resection in Patient With Hepatic Metastasis, sponsored by Centre Hospitalier Universitaire de Besancon. Terminated at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-08-06.
Sponsored by Centre Hospitalier Universitaire de Besancon · Phase 2/3, Interventional, and Treatment
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.
3,517 studies on the registry are indexed under Neoplasm Metastasis; 883 are open to participants now.
This study's enrollment of 29 is below the median of 54 across 2,765 interventional studies indexed under Neoplasm Metastasis.
Browse Neoplasm Metastasis studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 439 studies on the registry; 97 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Procedure: hepatic surgery of resection
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.
this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
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
Time frame: 3 years
LIVER RELEASE VALUE
DISSECTION PHASE BETWEEN INCISION AND PARTIAL OR TOTAL EXPOSITION OF LIVER
Time frame: 3 years
LOSS OF BLOOD
Time frame: 3 years
CoSeal tolerance
Time frame: 3 years
per operative complication
Time frame: 3 years
post operative complication
Time frame: 3 years
hospitalisation time
Time frame: 3 years
operative difficulty
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
de novo hepatic adherence extension
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
Time frame: 3 years
hepatic adherence reformation
Time frame: 3 years
adherence composite score
this is a mathematic score in relation with area and severity of liver adherence
Time frame: 3 years
composite score and surgery difficulty
this is a correlation between the composite score, the morbidity criteria and dissection difficulty
Time frame: 3 years
liver adherence score validation
Time frame: 3 years
This study is terminated, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon