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| Name | Class |
|---|---|
| Istituto Clinico Humanitas Mater Domini | OTHER |
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Endoscopic ultrasonography (EUS) with tissue acquisition (TA) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. Actually the standard methods to obtain sampling in gastrointestinal (GI) and non-GI solid masses is the fine needle aspiration (FNA) performed by endoscopic ultrasonography (EUS). Its sensitivity, specificity and diagnostic accuracy for malignant cytology are actually reported of 85-95%, 95%-98% and 78-95% respectively. These data could be affected by the presence of cytopathologist in endoscopy room during the tissue sampling. The rapid on-site evaluation (ROSE) has been advocated to significantly increase EUS-FNA accuracy. To overcome this problem fine needle biopsy (FNB) for TA to obtain histological specimens was proposed. These needles allow as the acquisition of an histological specimen than the cytological one with FNA needles. Recently, the need to obtain a histological, instead of a cytological, specimen during EUS has become more urgent and necessary due to innovative oncological treatment options. An acquired histological specimen could avoid the need of a cytopathologist in the endoscopic room, diminishing costs, procedures time, number of passes and reducing the additional costs of a possible repeated EUS-FNA, in case of an inconclusive diagnosis.
With the advent of FNB, the macroscopic on-site evaluation (MOSE) of the specimen by the endosonographer was proposed, resulting in a comparable alternative to ROSE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non MOSE arm | Experimental | Three needle passes will be performed for each mass |
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| MOSE arm | Experimental | The endoscopist will perform biopsy until a macroscopic visible core (MVC) will be obtained and specimen will be placed in a container (Container A-MOSE). If the needle passes performed are less than 3 (1 or 2 passes) the specimens acquired in the remnant passes to join standard care of 3 passes, according to ESGE guidelines, will be placed in a second container (Container B). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOSE | Other | After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the diagnostic accuracy of EUS-FNB with MOSE vs EUS-FNB alone. | Diagnostic accuracy will be measure | 12 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gastrointestinal Endoscopy Unit | Castellanza | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36044915 | Derived | Mangiavillano B, Crino SF, Facciorusso A, Di Matteo F, Barbera C, Larghi A, Rizzatti G, Carrara S, Spadaccini M, Auriemma F, Fabbri C, Binda C, Coluccio C, Marocchi G, Staiano T, Conti Bellocchi MC, Bernardoni L, Eusebi LH, Cirota GG, De Nucci G, Stigliano S, Manes G, Bonanno G, Ofosu A, Lamonaca L, Paduano D, Spatola F, Repici A. Endoscopic ultrasound-guided fine-needle biopsy with or without macroscopic on-site evaluation: a randomized controlled noninferiority trial. Endoscopy. 2023 Feb;55(2):129-137. doi: 10.1055/a-1915-5263. Epub 2022 Aug 31. |
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| ID | Term |
|---|---|
| C035456 | di-beta-(morpholinoethyl)selenide |
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