EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Subepithelial Gastrointestinal Tumors
- Sponsor
- Fondazione del Piemonte per l'Oncologia
- Enrollment
- 138
- Locations
- 7
- Primary Endpoint
- Evaluation of EUS-E accuracy qualitative
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with GI SETs scheduled for EUS-FNB 2 Patients with age \> 18 but \<85
Exclusion Criteria
- •Patients with GI SETs \<15mm
- •severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
- •severe cardiopulmonary diseases and severe chronic kidney disease defined as
- •known allergic disposition to SonoVue®
Outcomes
Primary Outcomes
Evaluation of EUS-E accuracy qualitative
Time Frame: 4 weeks
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: * homogeneously green-pattern (soft) * mixed-type pattern (mild stiffness) * blue-predominant elastographic pattern (hard) Strain Ratio (SR) will be calculated by dividing the ROI placed on the normal GI wall at the periphery of the mass (ROI B) by the ROI placed on the lesion itself (ROI A). ROI A will be manually adjusted to cover the tumoral area as much as possible.
Evaluation of EUS-E accuracy quantitative
Time Frame: 4 weeks
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.
Secondary Outcomes
- Complication rate (perforations, bleeding) of the procedure(48 hours)
- Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)(4 weeks)
- Evaluation of gene mutations in EUS-guided specimen(24 weeks)
- Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.(24 weeks)