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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03174327
Other study ID # 35RC17_9881_SUPERSONIC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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Study Design


Related Conditions & MeSH terms


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
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