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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Unknown status

CT.gov ID

NCT01874639

Collaborator

INNOPATH (Other), MEDTRONIC labs provide the aquamantys® probes for the study. (Other)

140

Enrollment

Location

Arms

Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Hepatectomy	Device: standard bipolar coagulation Device: Aquamantys® probe for liver hemostasis	Phase 2

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 conventional hemostasis using standard bipolar coagulation
Test group: hepatectomy with Aquamantys®

Study Design

Study Type:

Interventional

Anticipated Enrollment :

140 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hepatectomy ( conventional hemostasis ) 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
Other: hepatectomy with Aquamantys 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

Arm

Intervention/Treatment

Experimental: hepatectomy ( conventional hemostasis )

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

Other: hepatectomy with Aquamantys

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

Outcome Measures

Primary Outcome Measures

Blood loss during surgery [at day 0]

Secondary Outcome Measures

Duration of liver transection [at day 0]
Duration of surgery [at day 0]
Duration of hospital stay [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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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