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

NCT01874639 | Unknown Phase 2

• 1 other identifier: CHU-0156
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatectomy

Keywords

Hepatectomy; blood loss; hemostasis; coagulation; Liver surgery (benign or malign); Resection of 2 or more segments

Outcome Measures

Primary Outcomes (1)

• Blood loss during surgery

  at day 0

Secondary Outcomes (7)

• 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

Study Arms (2)

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

Device: 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®

Device: Aquamantys® probe for liver hemostasis

Interventions

standard bipolar coagulation DEVICE

hepatectomy ( conventional hemostasis )

Aquamantys® probe for liver hemostasis DEVICE

hepatectomy with Aquamantys

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• INNOPATH: collaborator
• MEDTRONIC labs provide the aquamantys® probes for the study.: collaborator

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Hemorrhage; Thrombosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Emmanuel BUC

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95; placarin@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2013
• First Posted: June 11, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 29, 2016

Record last verified: 2016-07

Locations

FR (1)