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NCT05448729 Clinical Trial

Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions

Endoscopic Ultrasonography Clinical Trial

Official title:
Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05448729
Other study ID # 396/2022
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date August 15, 2022
Est. completion date June 15, 2023

Study information
Verified date August 2022
Source Iuliu Hatieganu University of Medicine and Pharmacy
Contact Andrada Seicean, Prof
Phone 787802331
Email andradaseicean@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions

Description:

Three measurements of strain ratio elastography and three measurements of shear wave elastography with VPN> 20% will be performed in the same solid pancreatic lesions. The results will be compared in the groups of adenocarcinomas, neuroendocrine tumors and benign solid pancreatic lesions.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 15, 2023
Est. primary completion date December 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - patients with solid pancreatic masses > 2 cm in diameter at CT scan for EUS assessment Exclusion Criteria: - Patients with inconclusive pathology results - patients with cystic component > 20%

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Elastography EUS
Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

References & Publications (1)

Ohno E, Kawashima H, Ishikawa T, Iida T, Suzuki H, Uetsuki K, Yashika J, Yamada K, Yoshikawa M, Gibo N, Aoki T, Kataoka K, Mori H, Yamamura T, Furukawa K, Nakamura M, Hirooka Y, Fujishiro M. Diagnostic performance of endoscopic ultrasonography-guided elas — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic sensitivity Comparison between the diagnostic rate in both arms 12 months
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