SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS (SunnyDay021)

Fondazione del Piemonte per l'Oncologia

Status: Enrolling

Conditions: Subepithelial Gastrointestinal Tumors

Treatments: Procedure: EUS Elastography (EUS-E)

Study type: Observational

Funder types: Other

Identifiers

NCT06324032

021-FPO20

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

138 participants in 1 patient group

Patients with subepithelial gastrointestinal tumors

Description:

Patients with subepithelial gastrointestinal tumors

Treatment:

Procedure: EUS Elastography (EUS-E)