A Phase 2 interventional study of standard bipolar coagulation and Aquamantys® probe for liver hemostasis in Hepatectomy, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by University Hospital, Clermont-Ferrand · Phase 2, Interventional, and Treatment
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.
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:
3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.
This study's planned enrollment of 140 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.
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Exclusion Criteria:
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
Device: standard bipolar coagulation
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: - Test group: hepatectomy with Aquamantys®
Device: Aquamantys® probe for liver hemostasis
Blood loss during surgery
Time frame: at day 0
Duration of liver transection
Time frame: at day 0
Duration of surgery
Time frame: at day 0
Duration of hospital stay
Time frame: at day 1
Number of red blood cells transfusions
Time frame: at day 0
Number of frozen plasma transfusions
Time frame: at day 0
Volume of crystalloid and colloid fluids
Time frame: at day 0
Need of norepinephrine during the surgery
Time frame: at day 0
This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand