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临床试验/NCT01769248
NCT01769248已完成不适用

Randomized Prospective Trial of EUS-FNA Versus EUS-FNB Using a Novel Core Biopsy Needle

Northwestern University6 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2012年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
6
主要终点
Diagnostic Yield of EUS-FNB and EUS-FNA

研究概览

简要总结

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

The Echotip Procore (Cook Medical) core biopsy needle (ETP), has been demonstrated to provide excellent efficacy for core biopsy samples. Final diagnostic yield using this needle ranges from 80-90% and appears to be significantly greater than EUS-FNA for lesions requiring histology for diagnosis. However, there is currently only limited data from prospective studies comparing EUS-FNA to EUS-FNB with the ETP needle. The investigators propose a randomized, prospective, cross-over study comparing diagnostic accuracy of EUS-FNA to EUS-FNB.

详细描述

Endoscopic ultrasound (EUS) is paramount in the diagnosis and evaluation of cancers involving the gastrointestinal tract. EUS allows for the acquisition of cellular (fine needle aspirate - FNA) or tissue biopsy (fine needle biopsy - FNB) for diagnostic purposes. This has traditionally been done with fine needle aspirate where a needle is inserted into the tumor and potentially malignant cells are extracted for microscopic analysis. More recently, a needle that allows a tissue biopsy for histologic analysis has been FDA approved.

We will compare tissue samples obtained by standard FNA to FNB with a sample size of 140 patients with the primary outcome being diagnostic yield. Each patient will be randomized to FNA or FNA. If after 3 passes the on-site evaluation remains inadequate, the endoscopist will crossover to the other arm.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 3.1.1 All patients referred for EUS tissue sampling who provide informed consent

排除标准

  • 3.2.1 Coagulopathy which is not corrected
  • 3.2.2 Diagnostic EUS determines lesion is not amenable to FNA or FNB

研究组 & 干预措施

Fine needle aspiration

Active Comparator

fine needle aspiration

干预措施: Fine needle aspiration (Device)

Fine needle aspiration

Active Comparator

fine needle aspiration

干预措施: Fine needle biopsy (Device)

Fine needle biopsy

Active Comparator

Fine needle biopsy

干预措施: Fine needle aspiration (Device)

Fine needle biopsy

Active Comparator

Fine needle biopsy

干预措施: Fine needle biopsy (Device)

结局指标

主要结局

Diagnostic Yield of EUS-FNB and EUS-FNA

时间窗: 1 year

The investigators' primary outcome measure will assess the diagnostic yield (percentage of patients with a diagnosis) of EUS-FNB (fine-needle biopsy) to provide a final diagnosis of the lesion being sampled. This will be expressed as a percentage.

次要结局

  • Specimen Adequacy as Assessed by Rapid-onsite Evaluation of FNA and FNB(1 year)
  • Percentage of Patients in Whom a Diagnosis is Achieved After Crossover (%)(1 yr)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sri Komanduri

Associate Professor of Medicine

Northwestern University

研究点 (6)

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