Status:
UNKNOWN
Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study (HEPACOLL)
Lead Sponsor:
University Hospital, Clermont-Ferrand
Collaborating Sponsors:
INNOPATH
MEDTRONIC labs provide the aquamantys® probes for the study.
Conditions:
Hepatectomy
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
Blood loss in hepatic surgery is the main factor of postoperative morbidity. The use of the most effective possible tool for hemostasis allows a bleeding decrease during liver transection and thus cou...
Detailed Description
After validation of the inclusion and exclusion criteria, the patients include in this clinical trial will be randomized between the two arms of the study: * Control group: hepatectomy with conventio...
Eligibility Criteria
Inclusion
- Patients undergoing elective surgery for liver resection of malignant or benign disease
- Hepatic resection of two or more segments
- No coagulation disorder
- No portal hypertension (platelets ≥ 100 G/L, absence of splenomegaly, absence of portal hypertension varices)
- Obtaining the patient's written consent
Exclusion
- Age \< 18 years and \> 80 years
- ASA score \> 3
- Cirrhosis, liver fibrosis \> F2, steatosis \> 60%, sinusoidal obstruction syndrome
- Cognitive troubles and major disability making impossible to understand the study and signed the informed consent (e.g. dementia, psychiatric disorders like psychosis, speech disorder ...)
- Liver and kidney failure
- Pregnancy and lactating women
- Legal incapacity
- Patients already enrolled in a clinical trial
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT01874639
Start Date
June 1 2013
End Date
December 1 2016
Last Update
July 29 2016
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003