- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176290
Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation
June 2, 2017 updated by: Iman Fawzy Montasser, Ain Shams University
Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation: Is There Still a Rolefor Liver Biopsy?
The aim of this study is to compare prospectively the ability of MRE and Transient Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in patients who underwent Living Donor Liver Transplantation for complications related to HCV.
Study Overview
Status
Completed
Conditions
Detailed Description
The study included Patients transplanted for HCV related disease diagnosed by positive serum PCR (HCV RNA) and liver biopsy with elevated liver enzymes and/orhyperbilirubinemia with Normal Abdominal Doppler ultrasound and MRCP.Other aetiology for liver disease as indication for transplantation and other causes of post-transplant abnormal liver profile as Post transplant biliary stricture or vascular liver diseases (if unresolved) were excluded from the study.
Patients with active CMV infection(proved by positive CMV PCR or positive inclusion bodies by histopathology) were also excluded.
All patients were subjected toFull history taking and thorough clinical examination, Laboratory investigations including CBC, Liver profile tests, Albumin, Bilirubin (Total and Direct), ALP(Alkaline phosphatase), AST(Aspartate aminotransferase), ALT (Alanine aminotransferase), INR (International Normalization Ratio),HCV RNA quantitative,CMV PCR, AST/ platelet ratio, Alpha feto-protein and fibro alpha score
Study Type
Observational
Enrollment (Actual)
31
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients underwent Living donor liver transplantation for HCV related disease
Description
Inclusion Criteria:
- Adult recipients who are candidate for LDLT due to HCV related ESLD and meeting the transplantation criteria of the Ain Shams Center of Organ Transplantation (Child Pugh score ≥ 7and MELD score ≥15).
Exclusion Criteria:
- Adult recipients who underwent LDLT due to other causes rather than HCV. Cardiopulmonary disease that cannot be corrected and is a prohibitive risk for surgery Acquired immunodeficiency syndrome (AIDS) Malignancy outside of the liver not meeting oncologic criteria for cure Hepatocellular carcinoma with metastatic spread Anatomic abnormalities that preclude liver transplantation Uncontrolled sepsis Acute liver failure with a sustained intracranial pressure >50 mmHg or a cerebral perfusion pressure <40 mmH Persistent non adherence with medical care and Lack of adequate social support Advanced age older than 65y.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
compare between liver biopsy and Magnetic Resonance Elastography (MRE) in assessment of liver fibrosis in HCV recipients after living donor liver transplantation
Time Frame: 6 months
|
The aim of this study is to compare prospectively the ability of MRE and Transient Elastography in detection and staging of allograft fibrosis in comparison to Liver biopsy in patients who underwent Living Donor Liver Transplantation for complications related to HCV.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
June 2, 2017
First Submitted That Met QC Criteria
June 2, 2017
First Posted (Actual)
June 5, 2017
Study Record Updates
Last Update Posted (Actual)
June 5, 2017
Last Update Submitted That Met QC Criteria
June 2, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Assessment of liver fibrosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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