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

Recruiting

• Conditions: Subepithelial Gastrointestinal Tumors
• Interventions: Procedure: EUS Elastography (EUS-E)

• Registration Number: NCT06324032
• Lead Sponsor: Fondazione del Piemonte per l'Oncologia

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.

Study Timeline

• Study Start: 2020-12-17
• Status Verified: 2024-02
• Study First Submitted: 2024-02-15
• Study First Submitted QC: 2024-03-15
• Last Update Submitted: 2024-03-15
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

1. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age > 18 but <85

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with subepithelial gastrointestinal tumors	EUS Elastography (EUS-E)	Patients with subepithelial gastrointestinal tumors

Primary Outcome Measures

Name	Time	Method
Evaluation of EUS-E accuracy qualitative	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	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 Outcome Measures

Name	Time	Method
Complication rate (perforations, bleeding) of the procedure	48 hours	Complication rate (perforations, bleeding) of the procedure will be obtained by evaluating the number of complications
Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)	4 weeks	Evaluation of diagnostic accuracy of Endoscopic Ultrasound biopsy (EUS-biopsy) with fine needle biopsy (FNB).; Is obtained by evaluating the Strain Ratio (SR). Strain Ratio (SR) is a value resulting from the ratio between the stiffness of two user-defined areas within an elastogram ,which provides an objective evaluation of the hardness of lesion. Therefore, EUS-E has been applied to diseases of the pancreas, liver, prostate, lymphnodes, and other SETs
Evaluation of gene mutations in EUS-guided specimen	24 weeks	Evaluation of genetic mutations in ultrasound-guided endoscopic specimens by analyzing the tissue.; All specimens will undergo histopathological examination, immunohistochemical evaluation, and molecular analysis
Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.	24 weeks	Correlation of elastographic and contrastographic characteristics of SubEpithelial Tumors (SETs) with the pathological risk stratification.; The elasticity of the tissues will be evaluated, which presents itself as a chromatic spectrum of shades and expressed graphically in an elastogram. The green color represents medium stiffness, blue reflects the hardest tissue and red the softest tissue.

Trial Locations

Locations (7)

Ospedale Santa Maria della Scaletta; 🇮🇹 Imola, Bologna, Italy

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo; 🇮🇹 Candiolo, Turin,, Italy

AOU Maggiore della Carità; 🇮🇹 Novara, Italy

AOU Città della Salute e della Scienza di Torino, Ospedale Molinette; 🇮🇹 Turin, Italy

Ospedale Humanitas Mater Domini; 🇮🇹 Castellanza, Varese, Italy

Istituto Oncologico Veneto; 🇮🇹 Padova, Italy