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Brief Title: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Official Title: Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
Study ID: NCT02594943
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 Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Name: Jan Johansson, SrConsultant
Affiliation: Region Skåne
Role: PRINCIPAL_INVESTIGATOR