NCT03176290

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
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Fibro-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.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-12-01
• Completion: 2017-03-01
• First posted: 2017-06-05
• Last updated: 2017-06-05