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

NCT03174327 | Completed

• 1 other identifier: 35RC17_9881_SUPERSONIC
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatic Transplantation

Outcome Measures

Primary Outcomes (1)

• Hepatic graft stiffness in kPa without complication

  Average of the three measures taken consecutively

  Baseline

Secondary Outcomes (3)

• Hepatic graft stiffness in kPa with complication

  Baseline

• The performance indicator

  Baseline

• The value of the hepatic steatosis of the grafts in the form of a ratio

  Baseline

Study Arms (1)

Hepatic Transplantation

OTHER

Diagnostic Test: Hepatic Transplantation

Interventions

Hepatic Transplantation DIAGNOSTIC_TEST

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.

Also known as: Supersonic® , Fibroscan andHepatic Puncture-Biopsy

Hepatic Transplantation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

Related 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 transplantation. Eur J Gastroenterol Hepatol. 2020 Feb;32(2):222-230. doi: 10.1097/MEG.0000000000001500.

  PMID: 31464783 RESULT

Study Officials

• Anita Paisant

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2017
• First Posted: June 2, 2017
• Study Start: June 27, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2018
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)