跳至主要内容
临床试验/NCT02744651
NCT02744651终止不适用

EUS-Endodrill vs. EUS-FNA for Diagnosis of Submucosal Tumors in the Upper GI Tract

Region Skane2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
Region Skane
入组人数
4
试验地点
2
主要终点
Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.

研究概览

简要总结

Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:

  • Compare EUS-guided Endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (EUS-FNA) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper GI tract.

详细描述

Endodrill is a newly constructed biopsy tool for flexible endoscopic use. It uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. It was originally designed for sampling of tissue from submucosal lesions. The investigators first study of the instrument is now finished. Endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps.

In this study the investigators want to compare the Endodrill instrument with FNA (both modalities EUS-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper GI-tract. Patients diagnosed with suspected submucosal tumors in the upper GI-tract will be enrolled to this study. They will first go through examination with EUS. If the suspicion of a submucosal tumor is confirmed, the investigator will perform both EUS guided FNA and Endodrill biopsies in the same patient.The harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

研究设计

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with a suspected submucosal tumor in the upper GI tract that are available for both EUS-guided FNA and Endodrill biopsy

排除标准

  • Mental illness
  • Extreme co-morbidity

结局指标

主要结局

Number of correct histopathological diagnoses from submucosal tumors in the upper GI tract.

时间窗: 24 months

Number of biopsies with the correct histopathological diagnoses

次要结局

未报告次要终点

研究者

发起方
Region Skane
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Jeremiasen

Consultant Surgeon

Region Skane

研究点 (2)

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