Hepatic Transplantation Clinical Trial
— SUPERSONICOfficial title:
Evaluation of Hepatic Rigidity by Ultrasonic Impulse Elastography in Liver Transplant Patients (SUPERSONIC)
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Interventional study with minimal risks and constraints, prospective, mono-centric.
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. |
Country | Name | City | State |
---|---|---|---|
France | Rennes University Hospital | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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