Liver MetastasisHIFU-ARNCT02728167
Efficacy of HIFU-AR on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
A study testing Pre-coagulation of the liver parenchyma with HIFU in people with Liver Metastasis, run by Centre Leon Berard at 1 site in France.
Trial summary
The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Metastasis
- What is being tested?
- Pre-coagulation of the liver parenchyma with HIFU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2016to Aug 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the day of consenting to the study.
- Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.
- ECOG PS ≤ 1.
- Adequate bone marrow and liver function at baseline as defined below:
- Platelet count ≥ 100 x 109/l, and hemoglobin of ≥ 9 g/dl),
- Total bilirubin ≤ 1.5 x ULN, AST and ALT ≤ 5 x ULN.
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- Recovered from prior anti-neoplasic treatment-related toxicity (grade <2 persistent treatment-related toxicity as per CTCAE v4 are accepted).
- Willingness for follow-up visits.
- Covered by a medical insurance.
- Signed and dated informed consent document indicating that the patient has been informed of all aspects of the trial prior to enrolment.
Who cannot join
- Patients having previously undergone
- a major hepatic surgery (i.e. more than 3 liver segments) or
- biliary major surgery.
- Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.
- Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.
- Conditions
- Liver Metastasis
- Being tested
- Pre-coagulation of the liver parenchyma with HIFU
- Keywords
- Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-coagulation of the liver parenchyma with HIFUDevice
6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments
| Study group | Role | What they receive |
|---|---|---|
| Pre-coagulation by HIFU-AR | Experimental | Pre-coagulation of the liver parenchyma with HIFU and standard liver resection Receives: Device: Pre-coagulation of the liver parenchyma with HIFU |
| Standard liver resection | No intervention | Standard liver resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalized blood loss (ml/cm2)
To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection
Measured: During hepatectomy
Secondary outcomes (9)
Total blood los (ml)
Measured: During hepatectomy
Transection time
Measured: During hepatectomy
Transection time/cm2 of liver area (min/cm2)
Measured: During hepatectomy
Hemostasis time
Measured: During hepatectomy
Clip density on the liver section area
Number of clips/cm2
Measured: During hepatectomy
Rate of Pringle manoeuvre
Measured: During hepatectomy
Rate of patients needing a blood transfusion
Measured: During hepatectomy
Length of hospital stay
Measured: 10 days
Number of patients with postoperative complications assessed using Dindo-Clavien classification
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2018
- Study completionAug 2018
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel RIVOIRE, MD, PhD, Principal investigator, Centre Leon Bérard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728167
- Sponsor's protocol ID
- HIFU-AR
- Acronym
- HIFU-AR
- Status last verified
- Aug 2018
- First submitted
- 22 Mar 2016
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dupre A, Perol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.
PubMed 28166812
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-label, Phase II Study to Evaluate the Efficacy of High-Intensity Focused Ultrasound Assisted Hepatic Resection (HIFU-AR) on Blood Loss Reduction in Patients With Liver Metastases Requiring Hepatectomy
- ClinicalTrials.gov ID
- NCT02728167
- Acronym / sponsor ID
- HIFU-AR / HIFU-AR
- Conditions
- Liver Metastasis
- Keywords
- Hepatectomy, Liver metastasis, High-Intensity Focused Ultrasound, Liver metastases (LM) requiring surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 5 Apr 2016 (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.
The purpose of this study is to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss compared to standard liver resection in patients with LM.This is a prospective, monocentric, randomized (1:1 ratio), comparative, open-label Phase II study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-coagulation by HIFU-AR | Experimental | Device: Pre-coagulation of the liver parenchyma with HIFUPre-coagulation of the liver parenchyma with HIFU and standard liver resection |
| Standard liver resection | No intervention | –Standard liver resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years at the day of consenting to the study.
- Patients with liver metastases requiring a hepatectomy for ≥ 2 segments.
- ECOG PS ≤ 1.
- Adequate bone marrow and liver function at baseline as defined below:
- Recovered from prior anti-neoplasic treatment-related toxicity (grade <2 persistent treatment-related toxicity as per CTCAE v4 are accepted).
Key exclusion criteria (5 listed)
- Patients having previously undergone
- Patient with cirrhosis or sinusoidal obstruction syndrome with portal hypertension.
- Pregnant women (women of childbearing potential are required to have a negative pregnancy test within 72 hours prior to inclusion). A positive urine test must be confirmed by a serum pregnancy test.
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 |
|---|---|---|
| Pre-coagulation of the liver parenchyma with HIFU6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments | Device | Pre-coagulation by HIFU-AR |
Primary outcome
Normalized blood loss (ml/cm2)
Time frame: During hepatectomy
To compare the blood loss during hepactectomy in patients treated by HIFU-AR versus standard liver resection
9 secondary outcomes
Total blood los (ml)
Time frame: During hepatectomy
Transection time
Time frame: During hepatectomy
Transection time/cm2 of liver area (min/cm2)
Time frame: During hepatectomy
Hemostasis time
Time frame: During hepatectomy
Clip density on the liver section area
Time frame: During hepatectomy
Rate of Pringle manoeuvre
Time frame: During hepatectomy
Rate of patients needing a blood transfusion
Time frame: During hepatectomy
Length of hospital stay
Time frame: 10 days
Number of patients with postoperative complications assessed using Dindo-Clavien classification
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 28166812Dupre A, Perol D, Blanc E, Peyrat P, Basso V, Chen Y, Vincenot J, Kocot A, Melodelima D, Rivoire M. Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial. Trials. 2017 Feb 6;18(1):57. doi: 10.1186/s13063-017-1801-2.
- Individual participant dataSharing planned: No
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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.
Michel RIVOIRE, MD, PhD principal investigator
Centre Leon Bérard
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pre-coagulation of the liver parenchyma with HIFU in people with Liver Metastasis, run by Centre Leon Berard 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 10 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Aug 2018. 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.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalized blood loss (ml/cm2) (time frame: During hepatectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02728167, which also lists 1 linked publication.
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 15 Aug 2018.