Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)
Primary Purpose
Hepatic Transplantation
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Hepatic Transplantation
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatic Transplantation
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Rennes University Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Hepatic Transplantation
Arm Description
Outcomes
Primary Outcome Measures
Hepatic graft stiffness in kPa without complication
Average of the three measures taken consecutively
Secondary Outcome Measures
Hepatic graft stiffness in kPa with complication
Average of the three measures taken consecutively
The performance indicator
Evaluation of the diagnostic performance of Supersonic® and Fibroscan versus Hepatic Puncture-Biopsy (sensitivity, specificity, reproducibility).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174327
Brief Title
Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients
Acronym
SUPERSONIC
Official Title
Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 27, 2017 (Actual)
Primary Completion Date
April 24, 2018 (Actual)
Study Completion Date
April 24, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Transplantation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
63 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hepatic Transplantation
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Hepatic Transplantation
Other Intervention Name(s)
Supersonic® , Fibroscan andHepatic Puncture-Biopsy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hepatic graft stiffness in kPa without complication
Description
Average of the three measures taken consecutively
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Hepatic graft stiffness in kPa with complication
Description
Average of the three measures taken consecutively
Time Frame
Baseline
Title
The performance indicator
Description
Evaluation of the diagnostic performance of Supersonic® and Fibroscan versus Hepatic Puncture-Biopsy (sensitivity, specificity, reproducibility).
Time Frame
Baseline
Title
The value of the hepatic steatosis of the grafts in the form of a ratio
Description
The value of the hepatic steatosis of the grafts in the form of a ratio between the hepatic brightness and the renal brightness.
Time Frame
Baseline
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Paisant
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31464783
Citation
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.
Results Reference
result
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Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients
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