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

NCT ID: NCT05448729

Last Updated: 2022-08-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-06-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Endoscopic Ultrasonography

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Strain ratio Elastography EUS

The solid pancreatic lesion will be assessed by using strain ratio elastography EUS

Group Type SHAM_COMPARATOR

Elastography EUS

Intervention Type DIAGNOSTIC_TEST

Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis

Shear Wave Elastography EUS

The solid pancreatic lesion will be assessed by using shear wave elastography EUS

Group Type ACTIVE_COMPARATOR

Elastography EUS

Intervention Type DIAGNOSTIC_TEST

Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis

Interventions

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Elastography EUS

Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role lead

Responsible Party

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Professor Dr. Seicean Andrada

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrada Seicean, Prof

Role: PRINCIPAL_INVESTIGATOR

Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

Central Contacts

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Andrada Seicean, Prof

Role: CONTACT

787802331 ext. +40

Voicu Rednic, MD

Role: CONTACT

721926707 ext. +40

References

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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 elastography for solid pancreatic lesions: Shear-wave measurements versus strain elastography with histogram analysis. Dig Endosc. 2021 May;33(4):629-638. doi: 10.1111/den.13791. Epub 2020 Sep 15.

Reference Type RESULT
PMID: 32662150 (View on PubMed)

Related Links

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Other Identifiers

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396/2022

Identifier Type: -

Identifier Source: org_study_id

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