Clinical trial NCT06324032: SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS
Official title: EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subepithelial Gastrointestinal Tumors
Keywords: subepithelial gastrointestinal tumors
Endoscopic Ultrasound
EUS
SETs
EUS Elastography
surgical resection
histopatological specimens
Lead sponsor: Fondazione del Piemonte per l'Oncologia
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: for patients with all types of Gastro Intestinal SETs.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of EUS-E accuracy qualitative
timeFrame: 4 weeks
measure: Evaluation of EUS-E accuracy quantitative
timeFrame: 4 weeks
Secondary outcomes:
measure: Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)
timeFrame: 4 weeks
measure: Evaluation of gene mutations in EUS-guided specimen
timeFrame: 24 weeks
measure: Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.
timeFrame: 24 weeks
measure: Complication rate (perforations, bleeding) of the procedure
timeFrame: 48 hours
Other outcomes:
Locations:
city: Imola
country: Italy
facility: Ospedale Santa Maria della Scaletta
state: Bologna
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
city: Candiolo
country: Italy
facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
state: Turin,
city: Castellanza
country: Italy
facility: Ospedale Humanitas Mater Domini
state: Varese
city: Novara
country: Italy
facility: AOU Maggiore della Carità
city: Padova
country: Italy
facility: Istituto Oncologico Veneto
city: Turin
country: Italy
facility: AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
Study officials:
affiliation: FPO-IRCCS di Candiolo
name: Teresa Staiano, MD
role: PRINCIPAL_INVESTIGATOR
References: