Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation

Non-Invasive Assessment of Graft Fibrosis After Living Donor Liver Transplantation: Is There Still a Rolefor Liver Biopsy?

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03176290

Enrollment

Registered

2017-06-05

Start date

2014-12-31

Completion date

2017-03-31

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Brief summary

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.

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

Interventions

DIAGNOSTIC_TESTFibro-α score = (1.35 (numeric constant) +AFP (IU ml-1) × 0.009584 + aspartate aminotransferase (AST)/alanine aminotransferase(ALT) × 0.243 - platelet count (×109 l-1) × 0.001624).

Radiological investigations included Abdominal Doppler ultrasound, Magnetic Resonance Elastography(within 3 months of liver biopsy) and fibroscan.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
compare between liver biopsy and Magnetic Resonance Elastography (MRE) in assessment of liver fibrosis in HCV recipients after living donor liver transplantation	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026