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临床试验/NCT01501903
NCT01501903已完成不适用

Randomized Trial Comparing the Standard and Fanning Techniques for Fine Needle Aspiration of Pancreatic Mass Lesions at Endoscopic Ultrasound

Shyam Varadarajulu1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

Endoscopic Ultrasound (EUS)-guided biopsy is the most ideal technique for evaluating a growth in the pancreas. EUS-guided biopsies yield a definitive diagnosis in greater than 80% of cases. In 15-20% of the cases, a definitive diagnosis cannot be made despite multiple attempts. One of the reasons why a diagnosis cannot be made is due to the focal location of the cancer; i.e., the cancer can be situated in a corner of a big mass and the needle fails to sample the cancer cells. The fanning technique is a method where the needle moves in multiple directions within a mass and therefore there is a better chance of the cancer cells being sampled compared to the standard technique where the needle moves in only one direction. The diagnostic performance of both these techniques has not been compared in a randomized fashion.

详细描述

Fanning technique: Fine Needle Aspiration (FNA) performed in multiple directions within a mass.

Standard technique: FNA performed in unidirectional fashion.

研究设计

研究类型
Interventional
分配方式
Randomized
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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age > 19 years
  • •Solid Pancreatic Mass Lesions

排除标准

  • •Age < 19 years
  • •Coagulopathy
  • •Unable to consent

研究组 & 干预措施

Standard

Active Comparator

Biopsy using standard technique of FNA

干预措施: Standard (Procedure)

Fanning

Other

Biopsy using fanning technique

干预措施: Fanning (Procedure)

结局指标

主要结局

Diagnostic accuracy

时间窗: 2 months

The number of pancreatic masses that are correctly diagnosed with each needle type

次要结局

  • Number of passes for diagnosis(2 months)

研究者

发起方
Shyam Varadarajulu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shyam Varadarajulu

Principal Investigator

University of Alabama at Birmingham

研究点 (1)

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