Informations générales (source: ClinicalTrials.gov)
Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study
Interventional
Phase 2
University Hospital, Clermont-Ferrand (Voir sur ClinicalTrials)
juin 2013
décembre 2016
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France | Patrick LACARIN | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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