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临床试验/NCT02601079
NCT02601079终止不适用

Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia

Region Skane2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2016年9月最近更新:
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
7
试验地点
2
主要终点
Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.

研究概览

简要总结

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

  • Compare the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis based on collected biopsies of tumors in the upper GI tract.
  • Based on the quality of the collected tissue samples we want to evaluate which instrument generates the most useful material for genetic studies of the tumor.

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´s ability to obtain representative tissue samples from tumors in the distal esophagus and cardia with a conventional biopsy forceps. In addition the investigators want to compare the tissue samples in terms of weight, quality, artefacts and whether either instrument is more suited for collecting tissue for genetic analysis. Such analysis will be conducted with Next-Generation Sequensing (NGS) of the whole exome, Whole Exome Sequensing (WES). In the event of positive results from these analysis the investigators will also conduct RNA-sequencing of the tumor tissue in order to start pre-operative mapping of genetic abnormalities.

20 patients will be enrolled for this study. For each patient the investigators will collect 10 biopsies, 5 biopsies each with conventional biopsy and the Endodrill instrument respectively. The order will be randomized for each patient. For each specific biopsy the investigator will choose a particular site on the suspected tumor tissue without knowing which instrument that will be used for the biopsy. This procedure will be repeated for all 10 biopsies.

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

入选标准

  • Patients diagnosed with adenocarcinoma of the distal esophagus/cardia or stomach capable of stating a formal consent to participate in the study.

排除标准

  • Mental illness
  • Extreme co-morbidity (ASA >3)

结局指标

主要结局

Highest proportion (number) of representative biopsies for diagnostic purposes from the tumor tissue.

时间窗: 12 months

次要结局

  • Number of fusion genes in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.(12 months)
  • Number of genetic point mutations in tissue harvested from esophageal neoplasms prior to neoadjuvant oncological treatment.(12 months)

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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