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临床试验/NCT07480057
NCT07480057尚未招募不适用

Assessment of Changes in Bone Mineral Metabolism After Liver Transplantation by Bone Mineral Densitometry

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年3月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
assessment of changes in bone mineral mass (BMM) after living donor liver transplant

研究概览

简要总结

Liver transplantation (LT) remains the ultimate option to cure intractable end stage liver disease. Nutritional deficiencies are very common among CLD patients and due to this these patients suffer from low bone mineral density leading to osteoporosis and osteopenia. It has been observed that there is substantial reduction in bone density , especially within the first year of LT. The incidence of fractures among LT recipients has been reported to be around 3.5% with vertebral spine being the most common site. Multiple risk factors for osteoporosis after LT has been identified. Some of these include female sex, DM, sedentary lifestyle, pretransplant hypogonadism, Vit-D deficiency and pre-existing bone mineral abnormalities. Patients with CLD are also reported as having osteoblastic dysfunction by many factors, like unconjugated hyperbilirubinemia, decreased synthesis of collagen matrix, and decreased availability of insulin like growth factors. Post-transplant factors among LT recipients include: choice of immunosuppressive therapy like Glucocorticoid and CNIs therapy.

This Observational study aims to analyze the changes in bone mineral metabolism After Liver Transplantation by Bone Mineral Densitometry preoperatively and postoperatively. All eligible adult patients with Chronic Liver Disease undergoing Liver Transplant during the study period will be included in the study. These patients bone mineral density will be assessed using DEXA scan both preop and on Post op at 3 and 6 months. The association between the changes in BMM and various variables such as the sex of the patients, age of patients, etiology of CLD, presence of hepatocellular carcinoma (HCC), ICU stay, Hospital stay will be studied.

Pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (HIS) and radiological images collected from the hospital Picture archiving and communication system(PACS). The enrolled subjects will be followed up till for a period of 6 months after the Liver Transplant and the bone mineral density will be compared between these patients along with other parameters.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • - All adult patients >18 yrs with Cirrhosis of Liver undergoing Live Donor Liver Transplant

排除标准

  • Patients not giving consent.
  • Pediatric LT recipients
  • DDLT recipients

研究组 & 干预措施

CLD

All chronic liver disease undergoing living donor liver transplant.

干预措施: no intervention (Other)

ACLF

All acute on chronic liver failure patients undergoing living donor liver transplant.

干预措施: no intervention (Other)

结局指标

主要结局

assessment of changes in bone mineral mass (BMM) after living donor liver transplant

时间窗: preoperative and at 3 months and 6 months post LDLT

次要结局

  • evaluate the association between the changes in BMM with ICU stay and Hospital stay(preoperative and at 3 months and 6 months post LDLT)
  • evaluate the association between the changes in BMM and gender(preoperative and at 3 months and 6 months post LDLT)
  • evaluate the association between the changes in BMM and age of patients(preoperative and at 3 months and 6 months post LDLT)
  • evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC)(preoperative and at 3 months and 6 months post LDLT)
  • evaluate the association between the changes in BMM and etiology(preoperative and at 3 months and 6 months post LDLT)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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