Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endodrill vs. Conventional Biopsy. Evaluation of Diagnostic Capacity in Diffuse Gastric Cancer

Conditions
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Stomach Neoplasms

Intervention / Treatment
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* Device: Boston Scientific Large Capacity with needle Biopsy
* Device: Endodrill 1A (BIBBInstruments, Lund, Sweden)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: Mental illness Extreme co-morbidity (ASA>3)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Biopsy<br>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. | Device: Boston Scientific Large Capacity with needle Biopsy<br>* The investigators will use a conventional biopsy forceps for taking tissue biopsies in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the conventional biopsy forceps from the tumor tissue.<br>|
| Active Comparator: Endodrill Biopsy<br>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. | Device: Endodrill 1A (BIBBInstruments, Lund, Sweden)<br>* The investigators will use the Endodrill, a new device for endoscopic tissue sampling in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the Endodrill instrument from the tumor tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of (mm2 and %) submucosal tissue within the biopsies. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostics, Biopsy, Diffuse gastric cancer