Pancreatic CancerNCT02366858
Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures
A study testing 19 gauge and 22 gauge in people with Pancreatic Cancer, run by AdventHealth at 1 site in United States.
Trial summary
The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- 19 gauge and 22 gauge
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2015
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)
Who cannot join
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.
Read the detailed description
Inclusion Criteria
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
Exclusion Criteria
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
- Conditions
- Pancreatic Cancer
- Being tested
- 19 gauge, 22 gauge
- Keywords
- 19 gauge, 22 gauge, core tissue
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
19 gaugeProcedure or surgery
Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle
22 gaugeProcedure or surgery
Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle
| Study group | Role | What they receive |
|---|---|---|
| 19 gauge | Active comparator | Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle. Receives: Procedure: 19 gauge |
| 22 gauge | Active comparator | Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle. Receives: Procedure: 19 gauge; Procedure: 22 gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
22 gauge needle
Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained.
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2015 (estimated)
- Study startOct 2013
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: PI decision was made to discontinue the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02366858
- Sponsor's protocol ID
- 510467
- Status last verified
- Feb 2017
- First submitted
- 15 Jan 2014
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between the 19 and 22 Gauge Needles for Core Tissue Procurement During EUS-guided Procedures
- ClinicalTrials.gov ID
- NCT02366858
- Acronym / sponsor ID
- 510467
- Conditions
- Pancreatic Cancer
- Keywords
- 19 gauge, 22 gauge, core tissue
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI decision was made to discontinue the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 19 Feb 2015 (estimated)
- 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.
The investigators hypothesis is that a 22 gauge needle can yield core tissue, obviating the need to use the 19 gauge needle for core tissue procurement.
Detailed description
Inclusion Criteria
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
Exclusion Criteria
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19 gauge | Active comparator | Procedure: 19 gaugeEvaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle. |
| 22 gauge | Active comparator | Procedure: 19 gauge, Procedure: 22 gaugeEvaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are referred to Florida Hospital Center for Interventional Endoscopy for a EUS FNA for core biopsy (19 gauge needle biopsy) who have needle dysfunction (This occurs in about 10% of patients)
Key exclusion criteria (2 listed)
- Age under 19 years
- Pregnant women will be excluded. This will be confirmed by self-report
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 |
|---|---|---|
| 19 gaugeEvaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle | Procedure or surgery | 19 gauge, 22 gauge |
| 22 gaugeEvaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle | Procedure or surgery | 22 gauge |
Primary outcome
22 gauge needle
Time frame: 72 hours
Compare the quality of core tissue specimens obtained between a 19G and 22G needle by evaluating the ability to perform molecular marker studies or immunohistochemistry studies between samples obtained.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 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.
Shyam Varadarajulu, MD principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 19 gauge and 22 gauge in people with Pancreatic Cancer, run by AdventHealth at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 14 Feb 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
22 gauge needle (time frame: 72 hours). 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 14 Feb 2017.