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临床试验/NCT03307811
NCT03307811已完成不适用

Endoscopic Ultrasound Guided Liver Biopsy Using a 22 Gauge Fine Needle Biopsy Needle.

AdventHealth2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AdventHealth
入组人数
40
试验地点
2
主要终点
Diagnostic adequacy of the liver biopsy specimen

研究概览

简要总结

This is a prospective study to determine the optimal technique for obtaining liver tissue with a smaller caliber (22 gauge) needle and whether a good core biopsy can be obtained without the use of suction and secondly to determine the diagnostic yield and safety of 22 g Fine Needle Biopsy needle for liver biopsy.

详细描述

Liver biopsy (LB) has historically been performed by percutaneous route without image guidance (blind biopsy). However, in the last several years there has been more reliance on image guidance ultrasound-guided (USG) or computed tomography (CT) to direct the needle into the liver with the hope of limiting complications. Other ways of performing liver biopsy are transjugular fluoroscopy guided approach when percutaneous route is deemed not safe because of coagulopathy or ascites. Surgical LB (either laparoscopic or open) is yet another way of obtaining liver tissue.

Endoscopic ultrasound guided liver biopsy (EUS-LB) is proposed as a newer method that may offer several potential advantages over existing techniques for attaining liver tissue. It can be performed in an outpatient setting and offers the comfort of sedation and analgesia. Endoscopic Ultrasound (EUS) provides high resolution images of left lobe of the liver and a good portion of the right lobe of the liver. This coupled with Doppler capability the biopsy needle can be safely directed into the liver for sampling under real time image guidance. Intervening structures such as pleura, bowel loops and gallbladder can be easily seen by EUS and thus avoided that further decreases the risk of adverse events. It has been recognized that sampling error can lead to diagnostic inaccuracy of a biopsy from a single site. As compared to USG or CT scan the EUS allows easy and safe biopsy of both left and right lobes of the liver during same setting, potentially addressing concerns about sampling error.

The cost of the endoscopic procedure is the main expense of EUS-LB. Thus this approach is best used for patients requiring EUS for evaluation of elevated liver tests. If no obstructive lesion is identified by EUS that will require endoscopic retrograde cholangiopancreatography (ERCP) then it would cost-effective to perform EUS-LB during the same setting without much additional time and risks. This approach can spare the patient the additional discomfort and expense of a second dedicated LB procedure by any of the other available techniques (percutaneous, transjugular etc.). In such setting the equipment costs for the EUS-LB will mainly include only the Fine Needle Biopsy (FNB) needle, which is similar in expense to the cost of needles for the transjugular or percutaneous approach.

The traditionally used transcutaneous LB needle is 16 gauge (G) while largest EUS biopsy needle is 19 G. The smaller size of the needle is expected to decrease the complications rate (mainly pain and bleeding) even further. Many studies using a 19 G Tru-cut biopsy or Fine Needle Aspiration (FNA) needle to acquire liver tissue have obtained specimens adequate for histologic diagnosis but there has been a wide range of specimen adequacy (19-100%). The 19 G Tru-cut biopsy needle has been associated with several technical difficulties that could reflect negatively on tissue adequacy.

While it is easy and straight forward to biopsy the left lobe of the liver with any EUS needle. The 19 G needle is a large bore needle for EUS use and it is sometimes difficult to attain an adequate position for biopsy specially in duodenum where scope is torqued and this is the only area of access to right lobe.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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 patients referred to Florida Hospital Endoscopy Unit for assessment of elevated liver tests with EUS and are found to have no obstructive lesion to explain elevation of liver tests and will not require ERCP.
  • Age ≥ 19 years
  • Willing to provide informed consent verbal or written.

排除标准

  • Age <19 years
  • Unable to safely undergo EUS for any reason
  • Coagulopathy (INR >1.6, Thrombocytopenia with platelet count <50,000/ml) for subjects on anti-coagulation therapy.
  • Unwilling or cognitively unable to provide informed consent verbal or written.
  • Pregnancy (confirmed with Standard of Care urine pregnancy test for all women with child-bearing potential only)

结局指标

主要结局

Diagnostic adequacy of the liver biopsy specimen

时间窗: Sample obtained during EUS-guided liver biopsy.

Determine the diagnostic adequacy of the liver biopsy specimen by obtaining a histological specimen using a smaller (22 G) caliber needle. Diagnostic adequacy is defined as a sample that provides definitive pathological diagnosis (yes, no).

次要结局

  • Suction(Sample obtained during EUS-guided liver biopsy.)
  • Number of passes required histological samples(Time of Liver biopsy)
  • Visible core(Sample obtained during EUS-guided liver biopsy.)
  • Technical failure(Time of Liver biopsy)
  • Complications/Bleeding(1 month)
  • Complications/Pain(1 month)
  • Complications/Infection(1 Month)

研究者

发起方
AdventHealth
申办方类型
Other
责任方
Sponsor

研究点 (2)

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