Endoscopic UltrasonographyNCT03525847
The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
A study testing Endosonography in people with Endoscopic Ultrasonography, run by Professor Dr. Seicean Andrada at 1 site in Romania.
Trial summary
A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy Read more about this study
- Who is it for?
- Ages 18 to 86 years
- Conditions the study is for
- Endoscopic Ultrasonography
- What is being tested?
- Endosonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jan 2017to 1 Jan 2020
- 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 86 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- solid pancreatic tumor lesions
Who cannot join
- severe coagulopathy of trombocytopenia <50.000
- patients refuse for biopsy prelevation or pacient's refuse to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy
Read the detailed description
A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors
- Conditions
- Endoscopic Ultrasonography
- Being tested
- Endosonography
- Keywords
- Contrast endosonograpy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndosonographyDiagnostic test
Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization
| Study group | Role | What they receive |
|---|---|---|
| contrast enhanced FNA endosonography | Active comparator | First passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography Receives: Diagnostic Test: Endosonography |
| FNA standard endosonography | Active comparator | First passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography Receives: Diagnostic Test: Endosonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods
Measured: an average of 2 years
Secondary outcomes (3)
Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)
Visual analogic scale
Measured: 5 days
Dysfunction in the two types of biopsies
failure or difficulty reports with each procedure (%)
Measured: day one
Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core
Visual analogic scale
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start1 Jan 2017
- Primary completion1 Jan 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Professor Dr. Seicean Andrada
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Professor Dr. Seicean Andrada, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Seicean Andrada, Principal investigator, Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525847
- Sponsor's protocol ID
- 10430
- Status last verified
- Aug 2022
- First submitted
- 16 Nov 2017
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Study is used to show the superiority of CEUS-FNA endosonography Versus standard FNA endosonography in diagnosis of solid pancreatic masses
Publications
Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015.
PubMed 25793739Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x.
PubMed 21535197Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917.
PubMed 28218198
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
- The Added Value of Contrast Enhancement for Guiding EUS-FNA in Solid Pancreatic Masses
- ClinicalTrials.gov ID
- NCT03525847
- Acronym / sponsor ID
- 10430
- Conditions
- Endoscopic Ultrasonography
- Keywords
- Contrast endosonograpy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Professor Dr. Seicean AndradaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 16 May 2018 (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.
A prospective study designed to show the superiority of contrast guided echoendoscopy versus conventional echoendoscopy
Detailed description
A prospective study that compares the results using FNA contrast echoendoscopy versus standard FNA echoendoscopy in the diagnosis of solid pancreatic tumors
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| contrast enhanced FNA endosonography | Active comparator | Diagnostic Test: EndosonographyFirst passage in the solid pancreatic tumor using FNA endosonography then with the contrast enhanced FNA endosonography |
| FNA standard endosonography | Active comparator | Diagnostic Test: EndosonographyFirst passage in the solid pancreatic tumor using contrast enhanced FNA endosonography then with the FNA endosonography |
Who may qualify
- Ages
- 18 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- solid pancreatic tumor lesions
Key exclusion criteria (2 listed)
- severe coagulopathy of trombocytopenia <50.000
- patients refuse for biopsy prelevation or pacient's refuse to participate in the study
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 |
|---|---|---|
| EndosonographyPuncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization | Diagnostic test | FNA standard endosonography, contrast enhanced FNA endosonography |
Primary outcome
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods
Time frame: an average of 2 years
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods
3 secondary outcomes
Quality of histological specimen(histology core) obtained with the two types of FNA biopsies (contrast enhanced and standard)
Time frame: 5 days
Dysfunction in the two types of biopsies
Time frame: day one
Comparison between standand endosonography and contrast enhanced endosonography in obtaining a superior quality in obtaining histology core
Time frame: day one
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
- Background: PubMed 25793739Hou X, Jin Z, Xu C, Zhang M, Zhu J, Jiang F, Li Z. Contrast-enhanced harmonic endoscopic ultrasound-guided fine-needle aspiration in the diagnosis of solid pancreatic lesions: a retrospective study. PLoS One. 2015 Mar 20;10(3):e0121236. doi: 10.1371/journal.pone.0121236. eCollection 2015.
- Background: PubMed 21535197Yoshinaga S, Suzuki H, Oda I, Saito Y. Role of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for diagnosis of solid pancreatic masses. Dig Endosc. 2011 May;23 Suppl 1:29-33. doi: 10.1111/j.1443-1661.2011.01112.x.
- Results publication: PubMed 28218198Seicean A, Jinga M. Harmonic contrast-enhanced endoscopic ultrasound fine-needle aspiration: Fact or fiction? Endosc Ultrasound. 2017 Jan-Feb;6(1):31-36. doi: 10.4103/2303-9027.196917.
- Individual participant dataSharing planned: No. The Study is used to show the superiority of CEUS-FNA endosonography Versus standard FNA endosonography in diagnosis of solid pancreatic masses
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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.
Seicean Andrada principal investigator
Regional Institute of Gastroenterology and Hepatology "Octavian Fodor"Cluj-Napoca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endosonography in people with Endoscopic Ultrasonography, run by Professor Dr. Seicean Andrada at 1 site in Romania.
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: finished, 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.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CEUS FNA endosonography versus standard FNA endosonography in the etiological cyto histological of pancreatic solid tumors using histology core as comparison between the two methods (time frame: an average of 2 years). 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 NCT03525847, which also lists 3 linked publications.
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.