Pancreatic NeoplasmEUS-FNANCT03111368
EUS-FNA of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
A study testing Endoscopic ultrasound-guided fine needle aspiration in people with Pancreatic Neoplasm, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasm
- What is being tested?
- Endoscopic ultrasound-guided fine needle aspiration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 27 Apr 2015to 23 Jun 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pancreatic solid mass
Who cannot join
- endoscopic ultrasound non accessible lesions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.
Read the detailed description
The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.
- Conditions
- Pancreatic Neoplasm
- Being tested
- Endoscopic ultrasound-guided fine needle aspiration
- Keywords
- eus-fna, pancreatic neoplasm, slow-pull, negative pressure
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasound-guided fine needle aspirationProcedure or surgery
Also called EUS-FNA
pancreatic solid mass punctured with a 22G endoscopic ultrasound needle
| Study group | Role | What they receive |
|---|---|---|
| EUS- FNA Slow-pull | Active comparator | Endoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass Receives: Procedure: Endoscopic ultrasound-guided fine needle aspiration |
| EUS-FNA Negative Pressure | Active comparator | Endoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass Receives: Procedure: Endoscopic ultrasound-guided fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
cytological results after endoscopic ultrasound fine needle aspiration
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start27 Apr 2015
- Primary completion23 Jun 2016
- Study completion23 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation, Medi - Globe
- Responsible party
- Sponsor
- Investigators
- Spencer Cheng, Principal investigator, Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03111368
- Sponsor's protocol ID
- 41620315.9.0000.0068
- Acronym
- EUS-FNA
- Status last verified
- Jun 2016
- First submitted
- 1 Apr 2016
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Ultrasound-guided Fine Needle Aspiration (EUS-FNA) of Solid Pancreatic Mass: Comparison Between Negative Pressure and Slow-pull Technique
- ClinicalTrials.gov ID
- NCT03111368
- Acronym / sponsor ID
- EUS-FNA / 41620315.9.0000.0068
- Conditions
- Pancreatic Neoplasm
- Keywords
- eus-fna, pancreatic neoplasm, slow-pull, negative pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation, Medi - Globe
- Study start
- 27 Apr 2015 (actual)
- Primary completion
- 23 Jun 2016 (actual)
- Study completion
- 23 Jun 2016 (actual)
- First posted
- 12 Apr 2017 (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.
50 patients with pancreatic mass will undergo endoscopic ultrasound-guided fine needle aspiration using two techniques: negative pressure and slow-pull. Cytological results will be compared.
Detailed description
The study will analyze the cytological results of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) of pancreatic mass using two different techniques of needle suction. Negative pressure and slow-pull. 50 patients with pancreatic mass will be submitted to four passes with both techniques. Each patient will be randomized to decide which technique will be first and subsequently on a alternated fashion until four passes are completed. Smear cytology and cell block preparations for each technique were obtained. The pathologist was blinded for the EUS-FNA technique.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS- FNA Slow-pull | Active comparator | Procedure: Endoscopic ultrasound-guided fine needle aspirationEndoscopic ultrasound-guided fine needle aspiration using a stylet slow-pull technique of solid pancreatic mass |
| EUS-FNA Negative Pressure | Active comparator | Procedure: Endoscopic ultrasound-guided fine needle aspirationEndoscopic ultrasound-guided fine needle aspiration using negative pressure technique of solid pancreatic mass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- pancreatic solid mass
Key exclusion criteria (1 listed)
- endoscopic ultrasound non accessible lesions
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 |
|---|---|---|
| Endoscopic ultrasound-guided fine needle aspirationAlso: EUS-FNApancreatic solid mass punctured with a 22G endoscopic ultrasound needle | Procedure or surgery | EUS- FNA Slow-pull, EUS-FNA Negative Pressure |
Primary outcome
Diagnostic yield
Time frame: 24 months
cytological results after endoscopic ultrasound fine needle aspiration
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 12 Apr 2017.
- Individual participant dataSharing planned: No
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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.
Spencer Cheng principal investigator
Hospital das Clinicas Faculdade de Medicina da Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic ultrasound-guided fine needle aspiration in people with Pancreatic Neoplasm, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 1 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 12 Apr 2017. 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 Brazil. 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 yield (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2017.