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This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients
This will be a longitudinal, prospective, observational multicenter study that will enroll consecutive patients, with gastrointestinal SETs diagnosed by experienced endoscopists at Italian hospitals. This study will be conducted following the Helsinki Declaration after the approval by the ethics review board of all centers and will be recorded on Clinical-Trials.gov. All patients will provide their written informed consent for participating in the study. The EUS-E and CEUS analysis with SonoVue® will be performed during the same procedures. A subsequent diagnostic hypothesis on the nature of SETs will be formulated based on the B-mode, EUS-E, and CE-EUS characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with subepithelial gastrointestinal tumors | Patients with subepithelial gastrointestinal tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EUS Elastography (EUS-E) | Procedure | All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE & CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of EUS-E accuracy qualitative | Evaluation of Endoscopic Ultrasound -Elastography (EUS-E)) accuracy (qualitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. the elastographic qualitative pattern will be assessed and described using an elastographic score. ELASTOGRAPHIC SCORE: three elastographic patterns will be used to define the stiffness of the SETs:
| 4 weeks |
| Evaluation of EUS-E accuracy quantitative | Evaluation of Endoscopic Ultrasound -Elastography (EUS-E) accuracy (quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy. EUS-E compares the strain between the target area and other reference areas, to provide a semi-quantitative analysis of tissue stiffness. The SR (B/A quotients) will be calculated by the diagnostic US imaging system. The SRs will be measured and recorded 3 times in each procedure; the mean value will be considered as the final result for data analysis(to establish an SR cut-off to differentiate GIST from other SETs). Videos of 5 seconds will be recorded per each measurement. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB) | Evaluation of diagnostic accuracy of Endoscopic Ultrasound biopsy (EUS-biopsy) with fine needle biopsy (FNB). Is obtained by evaluating the Strain Ratio (SR). Strain Ratio (SR) is a value resulting from the ratio between the stiffness of two user-defined areas within an elastogram ,which provides an objective evaluation of the hardness of lesion. Therefore, EUS-E has been applied to diseases of the pancreas, liver, prostate, lymphnodes, and other SETs |
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Inclusion Criteria:
1. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age > 18 but <85
Exclusion Criteria:
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for patients with all types of Gastro Intestinal SETs.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cristiana Laudi, MD | Contact | +390119933413 | Cristiana.laudi@ircc.it | |
| Marco Asioli, Dr | Contact | +390119933463 | marco.asioli@ircc.it |
| Name | Affiliation | Role |
|---|---|---|
| Teresa Staiano, MD | FPO-IRCCS di Candiolo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale Santa Maria della Scaletta | Recruiting | Imola | Bologna | Italy |
contact the principal investigator
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Biopsy
|
| 4 weeks |
| Evaluation of gene mutations in EUS-guided specimen | Evaluation of genetic mutations in ultrasound-guided endoscopic specimens by analyzing the tissue. All specimens will undergo histopathological examination, immunohistochemical evaluation, and molecular analysis | 24 weeks |
| Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification. | Correlation of elastographic and contrastographic characteristics of SubEpithelial Tumors (SETs) with the pathological risk stratification. The elasticity of the tissues will be evaluated, which presents itself as a chromatic spectrum of shades and expressed graphically in an elastogram. The green color represents medium stiffness, blue reflects the hardest tissue and red the softest tissue. | 24 weeks |
| Complication rate (perforations, bleeding) of the procedure | Complication rate (perforations, bleeding) of the procedure will be obtained by evaluating the number of complications | 48 hours |
| Istituto Clinico Humanitas | Recruiting | Rozzano | Milano | Italy |
|
| Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo | Recruiting | Candiolo | Turin, | 10060 | Italy |
|
| Ospedale Humanitas Mater Domini | Recruiting | Castellanza | Varese | Italy |
|
| AOU Maggiore della Carità | Recruiting | Novara | 28100 | Italy |
|
| Istituto Oncologico Veneto | Recruiting | Padova | Italy |
|
| AOU Città della Salute e della Scienza di Torino, Ospedale Molinette | Recruiting | Turin | 10126 | Italy |
|
| ID | Term |
|---|---|
| D061765 | Endoscopic Ultrasound-Guided Fine Needle Aspiration |
| ID | Term |
|---|---|
| D044963 | Biopsy, Fine-Needle |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D061705 | Image-Guided Biopsy |
| D013048 | Specimen Handling |
| D018084 | Ultrasonography, Interventional |
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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