Clinical trial · Observational
SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS
EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
NCT06324032CI-TRIAL-00075282SunnyDay021unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Subepithelial Gastrointestinal Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EUS Elastography (EUS-E) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with subepithelial gastrointestinal tumors
- description
- Patients with subepithelial gastrointestinal tumors
- interventionNames
- Procedure: EUS Elastography (EUS-E)
Primary outcomes (2)
- measure
- Evaluation of EUS-E accuracy qualitative
- timeFrame
- 4 weeks
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1\. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age \> 18 but \<85 Exclusion Criteria: 1. Patients with GI SETs \<15mm 2. severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma 3. severe cardiopulmonary diseases and severe chronic kidney disease defined as 4. known allergic disposition to SonoVue® 5. pregnancy
References
Publications (0)
Data not yet available
No reference posted for this study.