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临床试验/NCT06469489
NCT06469489招募中不适用

Safety and Adequacy of Trans-jugular Liver Biopsy in Patients With Liver Disease: SAFE-TJLB Study

Institute of Liver and Biliary Sciences, India1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Number of patients with liver biopsy taken of more than 1.5 cm in length

研究概览

简要总结

Liver biopsy is considered the gold standard for the evaluation of acute and chronic liver disorders. Liver biopsy provides information regarding diagnosis, disease progression, and response to therapy in patients with chronic liver diseases. Trans-jugular liver biopsy (TJLB) consists of obtaining liver tissue through a rigid cannula introduced into one of the hepatic veins typically using jugular venous access. This approach reduces the risk of hemorrhage after biopsy because the bleeding resulting from the biopsy needle will drain into the hepatic veins. In the past, the specimens obtained by a transjugular approach were considered suboptimal compared with the samples obtained with percutaneous needles because they were smaller and more fragmented. TJLB was initially indicated for patients who had a contraindication to percutaneous biopsy such as those with a coagulopathy or congenital clotting disorders, ascites, acute liver failure, large amount of adipose tissue, and patients after liver transplantation. The clinical role of TJLB has expanded due to the possibility of performing hemodynamic evaluation of the hepatic and portal venous systems, which provides useful information and may guide therapy in patients with portal hypertension.

Lacuna in literature:

There is no prospective study in India evaluating the safety and efficacy of trans-jugular liver biopsy in patients with liver disease.

详细描述

Hypothesis:

Trans-jugular liver biopsy is safe, gives adequate sample for pathological examination in patients with liver disease.

Aim of study:

To evaluate safety and adequacy of trans-jugular liver biopsy in patient with liver disease.

Primary objective:

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-65 years age.
  • Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.

排除标准

  • 未提供

结局指标

主要结局

Number of patients with liver biopsy taken of more than 1.5 cm in length

时间窗: Day 0

Adverse event

时间窗: Day 7

次要结局

  • Number of patients with Complications- arrythmia, hematoma(Day 0)
  • Time of Fluro exposure(Day 0)
  • Procedural time (in and out of catheter)(Day 0)
  • Number of passes(Day 0)
  • Failure rate(Day 0)
  • Day care time(Day 1)
  • VAS: pain (Abdomen and Neck, pre and post procedure)(Day 0)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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