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| Name | Class |
|---|---|
| The Mediterranean Institute for Transplantation and Advanced Specialized Therapies | OTHER |
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To determine the yield of tissue biopsy specimen and the diagnostic accuracy of tissue acquisition using a newly developed 22 gauge needle in patients with solid lesions throughout the GI tract.
The use of 22 gauge needle to gather tissue samples under EUS guidance has not been associated with an increased risk, and no major complications have been described so far both for the 22 gauge Procore needle and for standard 22 gauge.20, 21 Potential benefits of this new needle are the possibility of increasing the chance of retrieving tissue specimens for histological examination, with the possibility of increasing the diagnostic accuracy of the procedure saving the need and the cost deriving from on-site cytopathology examination. This may reduce the need to repeat EUS procedures or other more invasive sampling procedures, including surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adominal neoplasms patients | Experimental | Patients in whom EUS-FNTA is performed with a novel type of biopsy neede. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fine Needle Tissue Acquisition | Other | diagnostic |
|
| Measure | Description | Time Frame |
|---|---|---|
| - Yield, as defined by the percentage of patients in whom a histologically interpretable specimen will be retrieved by EUS-FNTA. | diagnostic accuracy | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| rate of complications | - The rate of complications, divided in procedural complication (perforation, bleeding) occurring during the procedure and late complications (delayed bleeding, infection) occurring during the post-procedural observational period. | perioperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GUIDO COSTAMAGNA, PROF | Catholic University of the Sacred Heart | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ISMETT | Palermo | Italy | ||||
| Universita cattolica del sacro cuore |
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| ID | Term |
|---|---|
| D000008 | Abdominal Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Rome |
| Italy |