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

NCT ID: NCT01874639

Last Updated: 2016-07-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2016-12-31

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.

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®

Conditions

Hepatectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

standard bipolar coagulation

Intervention Type: DEVICE

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®

Group Type: OTHER

Aquamantys® probe for liver hemostasis

Intervention Type: DEVICE

Interventions

standard bipolar coagulation

Intervention Type: DEVICE

Aquamantys® probe for liver hemostasis

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

INNOPATH

UNKNOWN

Sponsor Role: collaborator

MEDTRONIC labs provide the aquamantys® probes for the study.

UNKNOWN

Sponsor Role: collaborator

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuel BUC

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Patrick LACARIN

Role: CONTACT

placarin@chu-clermontferrand.fr

04 73 75 11 95

Facility Contacts

Patrick LACARIN

Role: primary

placarin@chu-clermontferrand.fr

04 73 75 11 95

Other Identifiers

CHU-0156

Identifier Type: -

Identifier Source: org_study_id