Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Region Skane
- 主要终点
- Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer
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 the Endodrill instrument with conventional biopsy forceps in terms of ability to establish the correct diagnosis of diffuse gastric cancer based on collected biopsies from tumor tissue.
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 a group of patients diagnosed with or suspected diffuse gastric cancer. 20 patients will be enrolled for this study. For each patient the investigators will collect 8 biopsies, 4 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 8 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
- 否
入选标准
- •Patients with suspected or with an established diagnosis of diffuse gastric cancer who are capable of stating a formal consent to participate in the study.
排除标准
- •Mental illness
- •Extreme co-morbidity (ASA>3)
研究组 & 干预措施
Conventional Biopsy
4 out of 8 biopsies taken with a Boston Scientific Large capacity with needle biopsy forceps from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
干预措施: Boston Scientific Large Capacity with needle Biopsy (Device)
Endodrill Biopsy
4 out of 8 biopsies taken with the Endodrill 1A instrument from the suspected tumor tissue in the stomach. They will be taken in random order "blinded" for the person performing the examination.
干预措施: Endodrill 1A (BIBBInstruments, Lund, Sweden) (Device)
结局指标
主要结局
Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer
时间窗: 24 months
次要结局
- Amount of (mm2 and %) submucosal tissue within the biopsies.(24 months)
研究者
Martin Jeremiasen
Consultant Surgeon
Region Skane
