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

EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study

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

Study Overview

• Status: Recruiting
• Conditions: Subepithelial Gastrointestinal Tumors
• Intervention / Treatment: Procedure: EUS Elastography (EUS-E)

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 Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Cristiana Laudi, MD; Phone Number: +390119933413; Email: Cristiana.laudi@ircc.it
• Study Contact Backup: Name: Marco Asioli, Dr; Phone Number: +390119933463; Email: marco.asioli@ircc.it

Study Locations

• Italy
  • Novara, Italy, 28100
    • Recruiting
    • Aou Maggiore Della Carita
    • Contact: Pietro Occhipinti, MD
  • Padova, Italy
    • Recruiting
    • Istituto Oncologico Veneto
    • Contact: Alberto Fantin, MD
  • Turin, Italy, 10126
    • Recruiting
    • AOU Città della Salute e della Scienza di Torino, Ospedale Molinette
    • Contact: Claudio G. De Angelis, MD
  • Bologna
    • Imola, Bologna, Italy
      • Recruiting
      • Ospedale Santa Maria della Scaletta
      • Contact: Pietro Fusaroli, MD
  • Milano
    • Rozzano, Milano, Italy
      • Recruiting
      • Istituto Clinico Humanitas
      • Contact: Silvia Carrara, MD
  • Turin,
    • Candiolo, Turin,, Italy, 10060
      • Recruiting
      • Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo
      • Contact: Teresa Staiano, MD; Phone Number: +390119933413; Email: teresa.staiano@ircc.it
  • Varese
    • Castellanza, Varese, Italy
      • Recruiting
      • Ospedale Humanitas Mater Domini
      • Contact: Benedetto Mangiavillano, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

for patients with all types of Gastro Intestinal SETs.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with subepithelial gastrointestinal tumors	Procedure: 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; Other Names: Endoscopic Ultrasound (EUS); Contrast Enhanced-EUS (CE-EUS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)	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	4 weeks
Evaluation of gene mutations in EUS-guided specimen	Evaluation of genetic mutations in ultrasound-guided endoscopic specimens by analyzing the tissue. All specimens will undergo histopathological examination, immunohistochemical evaluation, and molecular analysis	24 weeks
Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.	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.	24 weeks
Complication rate (perforations, bleeding) of the procedure	Complication rate (perforations, bleeding) of the procedure will be obtained by evaluating the number of complications	48 hours

Collaborators and Investigators

• Sponsor: Fondazione del Piemonte per l'Oncologia
• Investigators: Principal Investigator: Teresa Staiano, MD, FPO-IRCCS di Candiolo

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2020
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: EUS; Endoscopic Ultrasound; surgical resection; subepithelial gastrointestinal tumors; SETs; EUS Elastography; histopatological specimens
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms
• Other Study ID Numbers: 021-FPO20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: contact the principal investigator

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No