Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study (HEPACOLL)

Hepatectomy Clinical Trial

Official title:

Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01874639
• Other study ID #: CHU-0156
• 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

• Hemorrhage
• Hepatectomy

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