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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01874639
Other study ID # CHU-0156
Secondary ID
Status Recruiting
Phase Phase 2
First received June 7, 2013
Last updated July 28, 2016
Start date June 2013
Est. completion date December 2016

Study information

Verified date July 2016
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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 could reduce postoperative morbidity.

In the past decade, the improvement of techniques of transection of the hepatic parenchyma was one of the most important factors to ensure the hepatectomy safety. But the clinical performances of these technological innovations (ultrasound dissectors, monopolar radiofrequency probes and dissection devices using pressurized water) remain still unclear.

The medical device of hemostasis Aquamantys® (Salient company, Innopath) use the technology of "transcollation" combining a source of radiofrequency associated with a conductive liquid (NaCl 0.9% solution). The system consists of a specific generator (Aquamantys Pump Generator®) and single-use probes (Aquamantys 2.3 BipolarSealer®). The energy of radiofrequency is delivered by two bipolar electrodes. The innovative aspect of this device consists in maintaining the tissue to a temperature of 100°C, while using a conductive liquid which acts as process of cooling and avoids the drying out of tissues, smoke, risks of electric arc and overheating met with conventional electrosurgery. This device allows the coagulation of blood vessels but also bile ducts. The Aquamantys® system could decrease the postoperative morbidity and mortality due to a decrease of blood loss and biliary leak. These clinical benefits could be translated by an improvement of the direct and indirect costs associated to the surgery. However the Aquamantys® technology has not been scientifically validated in the context of the hepatic surgery, and this technology is expensive due to the purchase of single-use bipolar probes (Aquamantys 2.3 BipolarSealer®) and to the investment in a generator (Aquamantys Pump Generator®).

Consequently, it is essential to realize a study measuring the clinical and medical economic impact of the transcollation technology (Aquamantys® device) in the hepatic surgery.


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 conventional hemostasis using standard bipolar coagulation

- Test group: hepatectomy with Aquamantys®


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
standard bipolar coagulation

Aquamantys® probe for liver hemostasis


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (3)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand INNOPATH, MEDTRONIC labs provide the aquamantys® probes for the study.

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss during surgery at day 0 No
Secondary Duration of liver transection at day 0 No
Secondary Duration of surgery at day 0 No
Secondary Duration of hospital stay at day 1 No
Secondary Number of red blood cells transfusions at day 0 No
Secondary Number of frozen plasma transfusions at day 0 No
Secondary Volume of crystalloid and colloid fluids at day 0 No
Secondary Need of norepinephrine during the surgery at day 0 No
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