肝病患者经颈静脉肝活检的安全性和充分性:SAFE-TJLB 研究
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.
研究概览
详细说明
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:
- Adequacy of trans-jugular liver biopsy
- Safety of trans-jugular liver biopsy
Secondary objective:
- Indications of liver biopsy
- Procedural time (in and out of catheter)
- Number of passes
- Failure rate
- Day care time
- VAS: pain (Abdomen and Neck, pre and post procedure)
- Complications- arrythmia, hematoma
- Time of Fluro exposure
Patients and methods Study Design A prospective, observational cohort study will be conducted in patients with suspected or known liver disease between November 2023 to May 2024 at the Institute of Liver and Biliary Sciences (ILBS), New Delhi.
Clinical protocol An informed consent was taken from patients with liver disease undergoing liver biopsy as per clinical indication. The following demographic data was recorded at inclusion: Age, gender, co-morbidities, type, and etiology of liver disease. Laboratory parameters include complete blood count, liver function tests, kidney function tests, INR. Severity of liver disease (MELD score, CTP score, AARC score). The study comprises two components: a retrospective component covering the period from January 2020 to May 2024, and a prospective component from June 2024 to May 2025.
研究类型
注册 (实际的)
联系人和位置
学习地点
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National Capital Territory of Delhi
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New Delhi、National Capital Territory of Delhi、印度、110070
- Institute of Liver & Biliary Sciences
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Liver Diseases of all etiologies
描述
Inclusion Criteria:
- 18-65 years age.
- Patient with suspected or known liver disease undergoing trans-jugular liver biopsy as per clinical indication.
Exclusion Criteria:
- None
学习计划
研究是如何设计的?
设计细节
- 观测模型:COHORT
- 时间观点:PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
接受经颈静脉肝活检的肝病患者
|
No intervention |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
肝活检长度超过1.5厘米的患者人数
大体时间:第 0 天
|
第 0 天
|
|
不良事件
大体时间:第 7 天
|
第 7 天
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
手术时间(进出导管)
大体时间:第 0 天
|
第 0 天
|
|
|
通过次数
大体时间:第 0 天
|
第 0 天
|
|
|
失败率
大体时间:第 0 天
|
第 0 天
|
|
|
出现并发症——心律失常、血肿的患者数量
大体时间:第 0 天
|
第 0 天
|
|
|
氟暴露时间
大体时间:第 0 天
|
第 0 天
|
|
|
日托时间
大体时间:第一天
|
第一天
|
|
|
VAS: pain (Abdomen and Neck, pre and post procedure)
大体时间:Day 0
|
VAS=10 is maximum pain |
Day 0
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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