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

August 24, 2022 updated by: Professor Dr. Seicean Andrada, Iuliu Hatieganu University of Medicine and Pharmacy
to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Strain ratio Elastography EUS
The solid pancreatic lesion will be assessed by using strain ratio elastography EUS
Diagnostic test: Elastography EUS
Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis
Active Comparator: Shear Wave Elastography EUS
The solid pancreatic lesion will be assessed by using shear wave elastography EUS
Diagnostic test: Elastography EUS
Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic sensitivity
Time Frame: 12 months
Comparison between the diagnostic rate in both arms
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Andrada Seicean, Prof, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2022

Primary Completion (Anticipated)

December 15, 2022

Study Completion (Anticipated)

June 15, 2023

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2022

Last Update Submitted That Met QC Criteria

August 24, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 396/2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patients inclusions in another medical center

IPD Sharing Time Frame

12 luni

IPD Sharing Access Criteria

Web connection

IPD Sharing Supporting Information Type

  • Study Protocol
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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