Clinical Trial: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Brief Summary:
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.
Detailed Summary:
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.
Sponsor: Region Skane
Current Primary Outcome: Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer [ Time Frame: 24 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Amount of (mm2 and %) submucosal tissue within the biopsies. [ Time Frame: 24 months ]
Original Secondary Outcome: Same as current
Information By: Region Skane
Dates:
Date Received: October 27, 2015
Date Started: June 2017
Date Completion: December 2018
Last Updated: February 7, 2017
Last Verified: February 2017
