HepatectomyPhase 2NCT01874639
Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study (HEPACOLL)
A Phase 2 study testing standard bipolar coagulation and Aquamantys® probe for liver hemostasis in people with Hepatectomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatectomy
- What is being tested?
- standard bipolar coagulation and Aquamantys® probe for liver hemostasis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Dec 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
About this study
Official title: Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study
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.
Read more
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.
Read the 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
- Being tested
- standard bipolar coagulation, Aquamantys® probe for liver hemostasis
- Keywords
- Hepatectomy, blood loss, hemostasis, coagulation, Liver surgery (benign or malign), Resection of 2 or more segments
- Medical subject headings
- Hemorrhage, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard bipolar coagulationDevice
Aquamantys® probe for liver hemostasisDevice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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® Receives: Device: Aquamantys® probe for liver hemostasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss during surgery
Measured: at day 0
Secondary outcomes (7)
Duration of liver transection
Measured: at day 0
Duration of surgery
Measured: at day 0
Duration of hospital stay
Measured: at day 1
Number of red blood cells transfusions
Measured: at day 0
Number of frozen plasma transfusions
Measured: at day 0
Volume of crystalloid and colloid fluids
Measured: at day 0
Need of norepinephrine during the surgery
Measured: at day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HepatectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- INNOPATH, MEDTRONIC labs provide the aquamantys® probes for the study.
- Responsible party
- Sponsor
- Investigators
- Emmanuel BUC, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874639
- Sponsor's protocol ID
- CHU-0156
- Status last verified
- Jul 2016
- First submitted
- 7 Jun 2013
- Last updated
- 29 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Transcollation Device to Decrease Blood Loss During Hepatic Resections: a Randomized Cohort Study
- ClinicalTrials.gov ID
- NCT01874639
- Acronym / sponsor ID
- CHU-0156
- Conditions
- Hepatectomy
- Keywords
- Hepatectomy, blood loss, hemostasis, coagulation, Liver surgery (benign or malign), Resection of 2 or more segments
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- INNOPATH, MEDTRONIC labs provide the aquamantys® probes for the study.
- Study start
- Jun 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hepatectomy ( conventional hemostasis ) | Experimental | Device: standard bipolar coagulationAfter 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 |
| hepatectomy with Aquamantys | Other | Device: Aquamantys® probe for liver hemostasisAfter 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® |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard bipolar coagulation | Device | hepatectomy ( conventional hemostasis ) |
| Aquamantys® probe for liver hemostasis | Device | hepatectomy with Aquamantys |
Primary outcome
Blood loss during surgery
Time frame: at day 0
7 secondary outcomes
Duration of liver transection
Time frame: at day 0
Duration of surgery
Time frame: at day 0
Duration of hospital stay
Time frame: at day 1
Number of red blood cells transfusions
Time frame: at day 0
Number of frozen plasma transfusions
Time frame: at day 0
Volume of crystalloid and colloid fluids
Time frame: at day 0
Need of norepinephrine during the surgery
Time frame: at day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel BUC principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing standard bipolar coagulation and Aquamantys® probe for liver hemostasis in people with Hepatectomy, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss during surgery (time frame: at day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2016.