Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)

Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)

Interventional study with minimal risks and constraints, prospective, mono-centric.

Study Overview

• Status: Completed
• Conditions: Hepatic Transplantation
• Intervention / Treatment: Diagnostic test: Hepatic Transplantation

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Hepatic Transplantation

Diagnostic test: Hepatic Transplantation; 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.; Other Names: Supersonic® , Fibroscan andHepatic Puncture-Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic graft stiffness in kPa without complication	Average of the three measures taken consecutively	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hepatic graft stiffness in kPa with complication	Average of the three measures taken consecutively	Baseline
The performance indicator	Evaluation of the diagnostic performance of Supersonic® and Fibroscan versus Hepatic Puncture-Biopsy (sensitivity, specificity, reproducibility).	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.	Baseline

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Anita Paisant, Rennes University Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2017
• Primary Completion (Actual): April 24, 2018
• Study Completion (Actual): April 24, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 23, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Rigidity
• Other Study ID Numbers: 35RC17_9881_SUPERSONIC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No