Stomach Neoplasms Clinical Trial
Official title:
Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer
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.
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.
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