Esophageal Neoplasm Clinical Trial
Official title:
Endodrill vs. Conventional Biopsy. Diagnostics and Genetic Analysis in Tumors of the Distal Esophagus and Cardia
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.
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.
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