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

Hepatic Transplantation Clinical Trial

— SUPERSONIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174327
• Other study ID #: 35RC17_9881_SUPERSONIC
• Status: Completed
• Phase: N/A
• Start date: June 27, 2017
• Est. completion date: April 24, 2018

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: April 24, 2018
• Est. primary completion date: April 24, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatic Transplantation
• Muscle Rigidity

Intervention

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.

Locations

Country	Name	City	State
France	Rennes University Hospital	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (1)

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 transplantat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatic graft stiffness in kPa without complication	Average of the three measures taken consecutively	Baseline
Secondary	Hepatic graft stiffness in kPa with complication	Average of the three measures taken consecutively	Baseline
Secondary	The performance indicator	Evaluation of the diagnostic performance of Supersonic® and Fibroscan versus Hepatic Puncture-Biopsy (sensitivity, specificity, reproducibility).	Baseline
Secondary	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