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Too narrow inclusion criteria. Impossible to recruit patients.
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Endodrill is a new instrument for biopsy sampling in the GI-channel. The purpose of this study is as follows:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Biopsy | Active Comparator | 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. |
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| Endodrill Biopsy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Boston Scientific Large Capacity with needle Biopsy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Highest proportion (number) of representative biopsies from tumors of diffuse gastric cancer | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Amount of (mm2 and %) submucosal tissue within the biopsies. | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Johansson, SrConsultant | Region Skane | Principal Investigator |
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| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D018279 | Carcinoma, Signet Ring Cell |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001707 | Biopsy, Needle |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Endodrill 1A (BIBBInstruments, Lund, Sweden) | Device | 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. |
|
| D004066 |
| Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018297 | Neoplasms, Cystic, Mucinous, and Serous |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
| D008919 | Investigative Techniques |