Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| INNOPATH | UNKNOWN |
| MEDTRONIC labs provide the aquamantys® probes for the study. | UNKNOWN |
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hepatectomy ( conventional hemostasis ) | Experimental | 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 |
|
| hepatectomy with Aquamantys | Other | 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® |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard bipolar coagulation | Device |
| ||
| Aquamantys® probe for liver hemostasis |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss during surgery | at day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of liver transection | at day 0 | |
| Duration of surgery | at day 0 | |
| Duration of hospital stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrick LACARIN | Contact | 04 73 75 11 95 | placarin@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel BUC | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand | Recruiting | Clermont-Ferrand | 63003 | France |
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Device |
|
| at day 1 |
| Number of red blood cells transfusions | at day 0 |
| Number of frozen plasma transfusions | at day 0 |
| Volume of crystalloid and colloid fluids | at day 0 |
| Need of norepinephrine during the surgery | at day 0 |
| D002318 | Cardiovascular Diseases |