NCT06324032

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 138 (estimated)
• Sponsor: Fondazione del Piemonte per l'Oncologia · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Subepithelial Gastrointestinal Tumors

Interventions

Type	Name	Description
PROCEDURE	EUS Elastography (EUS-E)	All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE \& CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software

Timeline

• Start date: 2020-12-17
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2024-03-21
• Last updated: 2024-03-21

Locations

7 sites across 1 country: Italy