跳至主要内容
临床试验/NCT05614973
NCT05614973招募中不适用

Efficacy and Safety of Percutaneous Liver Biopsy With Needle Tract Plugging on Outpatient Basis: a Randomized Study (COGEL Study; Coaxial With Gelatin)

Yonsei University2 个研究点 分布在 2 个国家目标入组 122 人开始时间: 2022年8月2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
122
试验地点
2
主要终点
Safety of percutaneous liver biopsy

研究概览

简要总结

A prospective, randomized, two-arm, single-center study to compare efficacy and safety of percutaneous ultrasound-guided liver biopsy of conventional method (multiple liver punctures) versus coaxial method followed by needle tract plugging.

详细描述

Adult patients who are referred for the ultrasound-guided percutaneous biopsy of focal liver lesion (larger than 1cm) to obtain three or more tissue cores are eligible for this study. Exclusion criteria are as follows: 1) unable to approach a target lesion under ultrasound-guidance; 2) severe coagulopathy; 3) unable to discontinue anticoagulant/antiplatelet medications for the duration proposed by 2019 Society of Interventional Radiology guidelines; 4) co-presence of amyloidosis, large amount of ascites, or acute hepatobiliary infections. All enrolled patients will be randomized into either the conventional group or coaxial/plugging group. The conventional group will undergo percutaneous liver biopsy for multiple tissue cores through multiple punctures of the liver capsule. The coaxial/plugging group will undergo percutaneous liver biopsy using a coaxial needle (single puncture of the liver capsule), which will be plugged by gelatin particles after obtaining multiple tissue cores. The biopsy will be performed on outpatient basis regardless of the randomized group, and the patients will be discharged after two hours of observation. The rate of biopsy-related complications including bleeding (minor and major) and diagnostic yield will be compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • All adult patients aged 19 years or older in this institution
  • Patients referred for imaging-guided percutaneous liver biopsy requiring three or more tissue cores
  • Patients who understand and consent to enrollment in this study
  • Target lesion diameter 1cm or larger, and the lesion is approachable under ultrasonography-guidance.

排除标准

  • Patients with severe psychologic disorder or mental retardation
  • Patients with poor cooperation
  • Severe coagulopathy
  • Hepatobiliary obstruction
  • Acute hepatobiliary infection
  • Large amount of ascites
  • Amyloidosis
  • Patients on antiplatelet/anticoagulant medication that cannot be discontinued for a specified period of time
  • Other patients whom the researchers deem ineligible

结局指标

主要结局

Safety of percutaneous liver biopsy

时间窗: Day 7 after procedure

Biopsy-related bleeding * Minor bleeding is defined as presence of linear flow signal along the needle tract on Doppler exam. * Major bleeding is defined as bleeding which requires transfusion or vascular embolization.

次要结局

  • Efficacy of percutaneous liver biopsy(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验