NCT05448729

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2023

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2022

Enrollment Period

4 months

First QC Date

July 2, 2022

Last Update Submit

August 24, 2022

Conditions

Endoscopic Ultrasonography

Keywords

elastography

Outcome Measures

Primary Outcomes (1)

  • Diagnostic sensitivity

    Comparison between the diagnostic rate in both arms

    12 months

Study Arms (2)

Strain ratio Elastography EUS

SHAM COMPARATOR

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

Diagnostic Test: Elastography EUS

Shear Wave Elastography EUS

ACTIVE COMPARATOR

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

Diagnostic Test: Elastography EUS

Interventions

Elastography EUSDIAGNOSTIC_TEST

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

Shear Wave Elastography EUSStrain ratio Elastography EUS

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with solid pancreatic masses \> 2 cm in diameter at CT scan for EUS assessment

You may not qualify if:

  • Patients with inconclusive pathology results
  • patients with cystic component \> 20%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 32662150RESULT

Related Links

Study Officials

  • Andrada Seicean, Prof

    Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrada Seicean, Prof

CONTACT

787802331andradaseicean@gmail.com

Voicu Rednic, MD

CONTACT

721926707rednicvoicu@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 2, 2022

First Posted

July 7, 2022

Study Start

August 15, 2022

Primary Completion

December 15, 2022

Study Completion

June 15, 2023

Last Updated

August 25, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will share

Patients inclusions in another medical center

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
12 luni
Access Criteria
Web connection