Pancreatic NeoplasmsNCT04002778
Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
A study testing Fine needle aspiration and Rapid on-site evaluation in people with Pancreatic Neoplasms, run by Universidade Federal do Rio de Janeiro.
Trial summary
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Neoplasms
- What is being tested?
- Fine needle aspiration and Rapid on-site evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Mar 2017
- 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
- solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
- formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.
Who cannot join
- a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
- lesions previously punctured on past EUS-FNA procedures
- American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
- cases of surveillance of solid pancreatic lesions
- severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0)
- impossibility of previous suspension of antiplatelet agents (except acetylsalicylic acid) or anticoagulants (all)
- patient unwillingness to participate
About this study
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.
Read the detailed description
Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.
- Conditions
- Pancreatic Neoplasms
- Being tested
- Fine needle aspiration, Rapid on-site evaluation
- Keywords
- EUS-FNA, pancreatic solid lesions, sample adequacy, cytopathology, endosonography
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fine needle aspirationDiagnostic test
Rapid on-site evaluationDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| ROSE by endosonographer | Active comparator | Submitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization Receives: Diagnostic Test: Fine needle aspiration; Diagnostic Test: Rapid on-site evaluation |
| non-ROSE | Other | Submitted to fine-needle aspiration. Receives: Diagnostic Test: Fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure duration
Minutes
Measured: Procedure
Secondary outcomes (4)
Specimen adequacy rate
Cases with a sample suitable for a definitive diagnosis over the total number of cases
Measured: Through study completion, an average of 18 months
Total number of passes
total number of passes of all procedures
Measured: Through study completion, an average of 18 months
Number of adverse events
Total number of adverse events of all procedures
Measured: Through study completion, an average of 18 months
Diagnostic yield
Cases in which a final diagnostic could be established over the total number of cases
Measured: Through study completion, an average of 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study startAug 2015
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic NeoplasmsStudies 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
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guilherme Rezende, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04002778
- Sponsor's protocol ID
- 45073415.3.0000.5257
- Status last verified
- Jun 2019
- First submitted
- 20 May 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid On-Site Evaluation (ROSE) by Endosonographer: for Whom, When and by Whom?
- ClinicalTrials.gov ID
- NCT04002778
- Acronym / sponsor ID
- 45073415.3.0000.5257
- Conditions
- Pancreatic Neoplasms
- Keywords
- EUS-FNA, pancreatic solid lesions, sample adequacy, cytopathology, endosonography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 1 Jul 2019 (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.
Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) is a highly sensitive and specific method in diagnosing solid pancreatic lesions. Rapid on-site evaluation (ROSE) of the aspirate by a cytopathologist improves specimen adequacy and diagnostic accuracy while reducing the number of needle passes. As this increases costs and implicates availability issues, the investigators aimed to evaluate the utility of ROSE by the endosonographer in guiding EUS-FNA of solid pancreatic lesions.
Detailed description
Consecutive patients with a solid pancreatic lesion were included. Endosonographer was submitted to a basic pancreatic cythpatology training programme at two institutitions. The patients were randomly allocated to the ROSE group - in which the number of needle passes required to obtain a sample suitable for cytopathologic categorization was established by the endosonographer's on-site evaluation - or to the non-ROSE group - in whom adequacy of the specimen was evaluated macroscopically and up to five needle passes could be performed, assuring sample adequacy. The gold standard was the final cytopathologist's diagnosis. The number of needle passes, procedure duration, specimen adequacy, diagnostic yield and adverse events rates were compared between groups and the performance measures of ROSE by endosonographer were determined.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ROSE by endosonographer | Active comparator | Diagnostic Test: Fine needle aspiration, Diagnostic Test: Rapid on-site evaluationSubmitted to fine-needle aspiration. Endosonographer's on-site evaluation of sample adequacy and categorization |
| non-ROSE | Other | Diagnostic Test: Fine needle aspirationSubmitted to fine-needle aspiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- solid pancreatic lesions detected by trans abdominal ultrasound or cross-sectional image (CT or MRI).
- formal indications to undergo EUS-FNA which were: differentiation between benign and malignant diseases, radiologic criteria of inoperability or unresectability, need for specific diagnosis which could modify therapeutic strategy and need for a diagnosis before neoadjuvant therapy.
Key exclusion criteria (7 listed)
- a cystic or solid cystic aspect of the pancreatic lesion on above mentioned image methods
- lesions previously punctured on past EUS-FNA procedures
- American Society of Anesthesiologist (ASA) Physical Status Classification System IV or V
- cases of surveillance of solid pancreatic lesions
- severe coagulation disorder (platelet count < 50000 or International Normalized Ratio > 2,0)
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 |
|---|---|---|
| Fine needle aspiration | Diagnostic test | ROSE by endosonographer, non-ROSE |
| Rapid on-site evaluation | Diagnostic test | ROSE by endosonographer |
Primary outcome
Procedure duration
Time frame: Procedure
Minutes
4 secondary outcomes
Specimen adequacy rate
Time frame: Through study completion, an average of 18 months
Total number of passes
Time frame: Through study completion, an average of 18 months
Number of adverse events
Time frame: Through study completion, an average of 18 months
Diagnostic yield
Time frame: Through study completion, an average of 18 months
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 1 Jul 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fine needle aspiration and Rapid on-site evaluation in people with Pancreatic Neoplasms, run by Universidade Federal do Rio de Janeiro.
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 2 inclusion and 7 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 1 Jul 2019. 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. 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?
Procedure duration (time frame: Procedure). 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 1 Jul 2019.