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

NCT06324032 | Recruiting

• 1 other identifier: 021-FPO20
• Study Type: observational
• Target: 138
• Locations: 1 country
• Sites: 7

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

Conditions

Subepithelial Gastrointestinal Tumors

Keywords

subepithelial gastrointestinal tumors; Endoscopic Ultrasound; EUS; SETs; EUS Elastography; surgical resection; histopatological specimens

Outcome Measures

Primary Outcomes (2)

• Evaluation of EUS-E accuracy qualitative

  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.

  4 weeks

• Evaluation of EUS-E accuracy quantitative

  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.

  4 weeks

Secondary Outcomes (4)

• Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)

  4 weeks

• Evaluation of gene mutations in EUS-guided specimen

  24 weeks

• Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.

  24 weeks

• Complication rate (perforations, bleeding) of the procedure

  48 hours

Study Arms (1)

Patients with subepithelial gastrointestinal tumors

Patients with subepithelial gastrointestinal tumors

Procedure: EUS Elastography (EUS-E)

Interventions

EUS Elastography (EUS-E) 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

Also known as: Endoscopic Ultrasound (EUS), Contrast Enhanced-EUS (CE-EUS)

Patients with subepithelial gastrointestinal tumors

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

for patients with all types of Gastro Intestinal SETs.

You may qualify if:

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

You may not qualify if:

• Patients with GI SETs \<15mm
• severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma
• severe cardiopulmonary diseases and severe chronic kidney disease defined as
• known allergic disposition to SonoVue®
• pregnancy

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (7)

Ospedale Santa Maria della Scaletta

Imola, Bologna, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Milano, Italy

RECRUITING

Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo

Candiolo, Turin,, 10060, Italy

RECRUITING

Ospedale Humanitas Mater Domini

Castellanza, Varese, Italy

RECRUITING

AOU Maggiore della Carità

Novara, 28100, Italy

RECRUITING

Istituto Oncologico Veneto

Padua, Italy

RECRUITING

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

Turin, 10126, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy

MeSH Terms

Interventions

Endoscopic Ultrasound-Guided Fine Needle Aspiration

Intervention Hierarchy (Ancestors)

Biopsy, Fine-Needle; Biopsy, Needle; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Image-Guided Biopsy; Specimen Handling; Ultrasonography, Interventional; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Teresa Staiano, MD

  FPO-IRCCS di Candiolo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristiana Laudi, MD

CONTACT

+390119933413; Cristiana.laudi@ircc.it

Marco Asioli, Dr

CONTACT

+390119933463; marco.asioli@ircc.it

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 21, 2024
• Study Start: December 17, 2020
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)