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Идёт набор NCT07480057

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

— Наблюдательное Chronic Liver Disease and ACLF

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: no intervention.
Кому может быть актуально
Состояния в реестре: Chronic Liver Disease and ACLF. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Индия
Следующий шаг
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Обзор

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.

Вмешательства

  • Другое no intervention
    No intervention as this is an observational study

Первичные конечные точки

  • assessment of changes in bone mineral mass (BMM) after living donor liver transplant [Срок оценки: preoperative and at 3 months and 6 months post LDLT]
Вторичные конечные точки (5)
  • evaluate the association between the changes in BMM and gender [Срок оценки: preoperative and at 3 months and 6 months post LDLT]
  • evaluate the association between the changes in BMM and age of patients [Срок оценки: preoperative and at 3 months and 6 months post LDLT]
  • evaluate the association between the changes in BMM and presence of hepatocellular carcinoma (HCC) [Срок оценки: preoperative and at 3 months and 6 months post LDLT]
  • evaluate the association between the changes in BMM and etiology [Срок оценки: preoperative and at 3 months and 6 months post LDLT]
  • evaluate the association between the changes in BMM with ICU stay and Hospital stay [Срок оценки: preoperative and at 3 months and 6 months post LDLT]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Индия · 1 центр
  • Institute of Liver and Biliary Sciences — New Delhi

Идентификаторы

NCT: NCT07480057 · ILBS-LT-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗