Endoscopic UltrasonographyNCT05448729
Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions
A study testing Elastography EUS in people with Endoscopic Ultrasonography, run by Iuliu Hatieganu University of Medicine and Pharmacy.
Trial summary
to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Endoscopic Ultrasonography
- What is being tested?
- Elastography EUS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2022to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with solid pancreatic masses > 2 cm in diameter at CT scan for EUS assessment
Who cannot join
- Patients with inconclusive pathology results
- patients with cystic component > 20%
Trial locations and contacts
No sites are listed yet.
About this study
to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions
Read the 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.
- Conditions
- Endoscopic Ultrasonography
- Being tested
- Elastography EUS
- Keywords
- elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elastography EUSDiagnostic test
Comparison between the values of strain ratio and shear wave in concordance with the final diagnosis
| Study group | Role | What they receive |
|---|---|---|
| Strain ratio Elastography EUS | Sham comparator | The solid pancreatic lesion will be assessed by using strain ratio elastography EUS Receives: Diagnostic Test: Elastography EUS |
| Shear Wave Elastography EUS | Active comparator | The solid pancreatic lesion will be assessed by using shear wave elastography EUS Receives: Diagnostic Test: Elastography EUS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic sensitivity
Comparison between the diagnostic rate in both arms
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Aug 2022 (estimated)
- Primary completion15 Dec 2022 (estimated)
- Study completion15 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Endoscopic UltrasonographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Dr. Seicean Andrada, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Andrada Seicean, Prof, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05448729
- Sponsor's protocol ID
- 396/2022
- Status last verified
- Aug 2022
- First submitted
- 2 Jul 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patients inclusions in another medical center
Publications
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.
PubMed 32662150
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shear Wave Elastography Versus Strain Elastography With Histogram Analysis in Solid Pancreatic Lesions
- ClinicalTrials.gov ID
- NCT05448729
- Acronym / sponsor ID
- 396/2022
- Conditions
- Endoscopic Ultrasonography
- Keywords
- elastography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- 15 Dec 2022 (estimated)
- Study completion
- 15 Jun 2023 (estimated)
- First posted
- 7 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
to assess the diagnostic value of strain elastography EUS and shear wave EUS in solid pancreatic lesions
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strain ratio Elastography EUS | Sham comparator | Diagnostic Test: Elastography EUSThe solid pancreatic lesion will be assessed by using strain ratio elastography EUS |
| Shear Wave Elastography EUS | Active comparator | Diagnostic Test: Elastography EUSThe solid pancreatic lesion will be assessed by using shear wave elastography EUS |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with solid pancreatic masses > 2 cm in diameter at CT scan for EUS assessment
Key exclusion criteria (2 listed)
- Patients with inconclusive pathology results
- patients with cystic component > 20%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastography EUSComparison between the values of strain ratio and shear wave in concordance with the final diagnosis | Diagnostic test | Shear Wave Elastography EUS, Strain ratio Elastography EUS |
Primary outcome
Diagnostic sensitivity
Time frame: 12 months
Comparison between the diagnostic rate in both arms
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Results publication: PubMed 32662150Ohno 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.
- DOI: 10.1111/den.13791Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patients inclusions in another medical center
Related trials for Endoscopic Ultrasonography
Recruiting
Determination of Pancreatic Steatosis Prevalence and Correlation With High-risk Cyst Features
Pancreatic Steatosis, Pancreatic Cyst
Not yet recruitingObservational study
Within-Session Repeatability of EUS-Guided Portal Pressure Gradient Measurement
Portal Hypertension, Chronic Liver Disease
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
Recruiting
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope
Pancreatic Disease, Pancreatic Cancer
RecruitingObservational study
EUS Procedures Using RIVOS™ EUS Access Device
Pancreatic Fluid Collections, Biliary Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrada Seicean, Prof principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy Cluj-Napoca
Questions about this trial
What is this clinical trial studying?
A study testing Elastography EUS in people with Endoscopic Ultrasonography, run by Iuliu Hatieganu University of Medicine and Pharmacy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrada Seicean, Prof (787802331 ext. +40, andradaseicean@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic sensitivity (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05448729, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2022.