Hepatic TransplantationSUPERSONICNCT03174327
Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients
A study testing Hepatic Transplantation in people with Hepatic Transplantation, run by Rennes University Hospital at 1 site in France.
Trial summary
Interventional study with minimal risks and constraints, prospective, mono-centric. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatic Transplantation
- What is being tested?
- Hepatic Transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2017to 24 Apr 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 years and over ;
- Hepatic transplant patient attending a day hospital of hepatology as part of the systematic follow-up of liver transplantation at 1 year, 5 years or 10 years in order to benefit from a clinical examination, biological evaluation, hepatic ultrasound, Fibroscan and Hepatic Puncture-Biopsy ;
- Patient in a position to receive information about the protocol ;
- Patient having given his / her written consent.
Who cannot join
- Coagulation disorder (platelets <60,000, Prothrombin Ratio <50%, partial thromboplastin time > 1.5 times the control unless explained by insufficient factor XII deficiency or anti-phospholipid antibodies);
- Ascites;
- Platelet antiaggregation taken the previous week biopsy, patient under anticoagulants;
- Persons of full age who are subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty;
- Patient not affiliated to social security;
- Pregnant or nursing women;
- Simultaneous participation in another research.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)
Interventional study with minimal risks and constraints, prospective, mono-centric.
Read the detailed description
Ultrasonic impulse elastography is a technique for studying non-invasive tissue rigidity. In particular, it is used in hepatology to assess the degree of fibrosis in a simple manner, by eliminating, in a number of cases, liver biopsy. The investigation of fibrosis is an essential element in the follow-up of patients with hepatic transplant since it is the indirect sign of a post-transplant complication or a recurrence of the initial disease.
Several elastography devices are available on the market, using different technologies to measure the rigidity of tissues. Studies have shown that the first hepatic elastography devices, Fibroscan® and Acoustic Radiation Force Impulse (ARFI) can detect significant fibrosis on hepatic grafts accurately and reproducibly. However, there are several factors related to patients or to the elastography apparatus itself, limiting its use by making the collection of measurements impossible or by giving outliers. In addition, first-generation devices (Fibroscan®) are not coupled to a conventional ultrasound system and are dedicated to the measurement of hepatic rigidity, so patients must undergo systematic ultrasound as part of graft follow-up .
Supersonic® (SuperSonic Imagine, Aix-en-Provence, France) is part of the latest generation of elastography devices and is based on ultrafast shearwave elastography (SWE) technology. This device is a conventional ultrasound system for routine ultrasound scanning with an integrated module for measuring tissue stiffness, and has the advantage of establishing real-time mappings of tissue rigidity over a large area. Several studies have shown that the measurements were reliable and reproducible, especially in the assessment of liver stiffness. In the literature, only one study addressed the measurement of hepatic rigidity with the Supersonic® ultrasound system in liver transplant patients and was designed to diagnose viral hepatitis recurrence or acute cellular rejection. In the secondary results, the authors found a significantly higher hepatic rigidity of healthy hepatic grafts compared to healthy native livers.
It is proposed to add to the ultrasound of systematic follow-up of the hepatic grafts carried out in clinical routine an elastographic measurement in order to assess the hepatic rigidity in these patients in a non-invasive way.
- Conditions
- Hepatic Transplantation
- Being tested
- Hepatic Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic TransplantationDiagnostic test
Also called Supersonic® , Fibroscan andHepatic Puncture-Biopsy
Systematic long-term monitoring of liver transplant patients includes an annual consultation and more comprehensive follow-up at one year, 5 years and 10 years of transplantation during which patients are hospitalized in day hospital hepatology and have a clinical examination Complete, biological assessment, Fibroscan® graft elastography measurement, hepatic Doppler ultrasound and liver biopsy. Measurement of liver stiffness by SuperSonic® will be added during ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Transplantation | Other | Not described Receives: Diagnostic Test: Hepatic Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatic graft stiffness in kPa without complication
Average of the three measures taken consecutively
Measured: Baseline
Secondary outcomes (3)
Hepatic graft stiffness in kPa with complication
Average of the three measures taken consecutively
Measured: Baseline
The performance indicator
Evaluation of the diagnostic performance of Supersonic® and Fibroscan versus Hepatic Puncture-Biopsy (sensitivity, specificity, reproducibility).
Measured: Baseline
The value of the hepatic steatosis of the grafts in the form of a ratio
The value of the hepatic steatosis of the grafts in the form of a ratio between the hepatic brightness and the renal brightness.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start27 Jun 2017
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
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 Hepatic TransplantationStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Paisant, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174327
- Sponsor's protocol ID
- 35RC17_9881_SUPERSONIC
- Acronym
- SUPERSONIC
- Status last verified
- May 2023
- First submitted
- 30 May 2017
- Last updated
- 23 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dubois M, Ronot M, Houssel-Debry P, Brun V, Rayar M, Auger M, Beuzit L, Turlin B, Aube C, Paisant A. Performance of B-mode ratio and 2D shear wave elastography for the detection and quantification of hepatic steatosis and fibrosis after liver transplantation. Eur J Gastroenterol Hepatol. 2020 Feb;32(2):222-230. doi: 10.1097/MEG.0000000000001500.
PubMed 31464783
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)
- ClinicalTrials.gov ID
- NCT03174327
- Acronym / sponsor ID
- SUPERSONIC / 35RC17_9881_SUPERSONIC
- Conditions
- Hepatic Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 2 Jun 2017 (actual)
- 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.
Interventional study with minimal risks and constraints, prospective, mono-centric.
Detailed description
Ultrasonic impulse elastography is a technique for studying non-invasive tissue rigidity. In particular, it is used in hepatology to assess the degree of fibrosis in a simple manner, by eliminating, in a number of cases, liver biopsy. The investigation of fibrosis is an essential element in the follow-up of patients with hepatic transplant since it is the indirect sign of a post-transplant complication or a recurrence of the initial disease.
Several elastography devices are available on the market, using different technologies to measure the rigidity of tissues. Studies have shown that the first hepatic elastography devices, Fibroscan® and Acoustic Radiation Force Impulse (ARFI) can detect significant fibrosis on hepatic grafts accurately and reproducibly. However, there are several factors related to patients or to the elastography apparatus itself, limiting its use by making the collection of measurements impossible or by giving outliers. In addition, first-generation devices (Fibroscan®) are not coupled to a conventional ultrasound system and are dedicated to the measurement of hepatic rigidity, so patients must undergo systematic ultrasound as part of graft follow-up .
Supersonic® (SuperSonic Imagine, Aix-en-Provence, France) is part of the latest generation of elastography devices and is based on ultrafast shearwave elastography (SWE) technology. This device is a conventional ultrasound system for routine ultrasound scanning with an integrated module for measuring tissue stiffness, and has the advantage of establishing real-time mappings of tissue rigidity over a large area. Several studies have shown that the measurements were reliable and reproducible, especially in the assessment of liver stiffness. In the literature, only one study addressed the measurement of hepatic rigidity with the Supersonic® ultrasound system in liver transplant patients and was designed to diagnose viral hepatitis recurrence or acute cellular rejection. In the secondary results, the authors found a significantly higher hepatic rigidity of healthy hepatic grafts compared to healthy native livers.
It is proposed to add to the ultrasound of systematic follow-up of the hepatic grafts carried out in clinical routine an elastographic measurement in order to assess the hepatic rigidity in these patients in a non-invasive way.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Transplantation | Other | Diagnostic Test: Hepatic Transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged 18 years and over ;
- Hepatic transplant patient attending a day hospital of hepatology as part of the systematic follow-up of liver transplantation at 1 year, 5 years or 10 years in order to benefit from a clinical examination, biological evaluation, hepatic ultrasound, Fibroscan and Hepatic Puncture-Biopsy ;
- Patient in a position to receive information about the protocol ;
- Patient having given his / her written consent.
Key exclusion criteria (7 listed)
- Coagulation disorder (platelets <60,000, Prothrombin Ratio <50%, partial thromboplastin time > 1.5 times the control unless explained by insufficient factor XII deficiency or anti-phospholipid antibodies);
- Ascites;
- Platelet antiaggregation taken the previous week biopsy, patient under anticoagulants;
- Persons of full age who are subject to legal protection (safeguard of justice, guardianship, guardianship), persons deprived of their liberty;
- Patient not affiliated to social security;
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 |
|---|---|---|
| Hepatic TransplantationAlso: Supersonic® , Fibroscan andHepatic Puncture-BiopsySystematic long-term monitoring of liver transplant patients includes an annual consultation and more comprehensive follow-up at one year, 5 years and 10 years of transplantation during which patients are hospitalized in day hospital hepatology and have a clinical examination Complete, biological assessment, Fibroscan® graft elastography measurement, hepatic Doppler ultrasound and liver biopsy. Measurement of liver stiffness by SuperSonic® will be added during ultrasound. | Diagnostic test | Hepatic Transplantation |
Primary outcome
Hepatic graft stiffness in kPa without complication
Time frame: Baseline
Average of the three measures taken consecutively
3 secondary outcomes
Hepatic graft stiffness in kPa with complication
Time frame: Baseline
The performance indicator
Time frame: Baseline
The value of the hepatic steatosis of the grafts in the form of a ratio
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Results publication: PubMed 31464783Dubois M, Ronot M, Houssel-Debry P, Brun V, Rayar M, Auger M, Beuzit L, Turlin B, Aube C, Paisant A. Performance of B-mode ratio and 2D shear wave elastography for the detection and quantification of hepatic steatosis and fibrosis after liver transplantation. Eur J Gastroenterol Hepatol. 2020 Feb;32(2):222-230. doi: 10.1097/MEG.0000000000001500.
- 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.
Anita Paisant principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic Transplantation in people with Hepatic Transplantation, run by Rennes University Hospital 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 23 May 2023. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Hepatic graft stiffness in kPa without complication (time frame: Baseline). 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 NCT03174327, 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 23 May 2023.