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临床试验/NCT03176290
NCT03176290已完成不适用

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

Ain Shams University0 个研究点目标入组 31 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
31
主要终点
compare between liver biopsy and Magnetic Resonance Elastography (MRE) in assessment of liver fibrosis in HCV recipients after living donor liver transplantation

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Iman Fawzy Montasser

Clinical professor

Ain Shams University

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