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

NCT ID: NCT06324032

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-17

Study Completion Date

2025-12-31

Brief Summary

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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

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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

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Subepithelial Gastrointestinal Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with subepithelial gastrointestinal tumors

Patients with subepithelial gastrointestinal tumors

EUS Elastography (EUS-E)

Intervention Type PROCEDURE

All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE \& CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software

Interventions

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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

Intervention Type PROCEDURE

Other Intervention Names

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Endoscopic Ultrasound (EUS) Contrast Enhanced-EUS (CE-EUS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione del Piemonte per l'Oncologia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Teresa Staiano, MD

Role: PRINCIPAL_INVESTIGATOR

FPO-IRCCS di Candiolo

Locations

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Ospedale Santa Maria della Scaletta

Imola, Bologna, Italy

Site Status RECRUITING

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Site Status RECRUITING

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin,, Italy

Site Status RECRUITING

Ospedale Humanitas Mater Domini

Castellanza, Varese, Italy

Site Status RECRUITING

AOU Maggiore della Carità

Novara, , Italy

Site Status RECRUITING

Istituto Oncologico Veneto

Padua, , Italy

Site Status RECRUITING

AOU Città della Salute e della Scienza di Torino, Ospedale Molinette

Turin, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Cristiana Laudi, MD

Role: CONTACT

+390119933413

Marco Asioli, Dr

Role: CONTACT

+390119933463

Facility Contacts

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Pietro Fusaroli, MD

Role: primary

Silvia Carrara, MD

Role: primary

Teresa Staiano, MD

Role: primary

+390119933413

Benedetto Mangiavillano, MD

Role: primary

Pietro Occhipinti, MD

Role: primary

Alberto Fantin, MD

Role: primary

Claudio G. De Angelis, MD

Role: primary

Other Identifiers

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021-FPO20

Identifier Type: -

Identifier Source: org_study_id

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