Pancreatic CancerNCT01809028
Evaluating the Number of Passes Required for Diagnostic Cell Block During EUS-FNA of Solid Pancreatic Mass Lesions
A study testing EUS FNA with 2 passes and EUS FNA with 4 passes in people with Pancreatic Cancer, run by AdventHealth at 1 site in United States.
Trial summary
This study will test the amount of tissue, called "cell block", obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Read more about this study
- Who is it for?
- Ages 19 to 89 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- EUS FNA with 2 passes and EUS FNA with 4 passes
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Jan 2014
- 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 19 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA.
Who cannot join
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients.
- Participation in any other Clinical Trial (excluding registries and databases)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions
This study will test the amount of tissue, called "cell block", obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number of times the doctor biopsies the mass), at this time we do not know the ideal number of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
Read the detailed description
Primary Aim:
To compare the number of passes required for obtaining adequate cell block material during EUS-guided FNA of solid pancreatic mass lesions.
Primary Research Hypothesis:
More specimen is required to obtain definitive diagnosis on cell block. This translates to less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA passes), prompt treatment to patients and better use of health care resources. Therefore, we will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an adequate diagnostic cell block.
Secondary Aims:
To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid pancreatic mass lesions.
Secondary Research Hypothesis:
EUS-guided FNA is a safe procedure with a complication rate of < 1%. By performing more (four) NA passes one is likely to yield a better quality cell block while at the same time without compromising patient safety.
- Conditions
- Pancreatic Cancer
- Being tested
- EUS FNA with 2 passes, EUS FNA with 4 passes
- Keywords
- cell block, number of passes
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EUS FNA with 2 passesProcedure or surgery
Also called Biopsy, FNA
biopsy with 2 passes
EUS FNA with 4 passesProcedure or surgery
Also called biopsy, FNA
biopsy with 4 passes
| Study group | Role | What they receive |
|---|---|---|
| EUS FNA with 2 passes | Active comparator | biopsy with 2 passes of the needle Receives: Procedure: EUS FNA with 2 passes |
| EUS FNA with 4 passes | Active comparator | biopsy with 4 passes of the needle Receives: Procedure: EUS FNA with 4 passes |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of passes
The primary endpoint of the study is to compare the number of passes required to make definitive diagnosis on cell block. This will be assessed by amount (quantity) of the sample to make the diagnosis proportionate to which group the subject was randomized to (two passes versus four passes).
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2014
- Study completionJan 2014
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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Responsible party
- Sponsor
- Investigators
- Shyam Varadarajulu, MD, Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01809028
- Sponsor's protocol ID
- 407129
- Status last verified
- Aug 2017
- First submitted
- 26 Feb 2013
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Varadarajulu S, Bang JY, Holt BA, Hasan MK, Logue A, Hawes RH, Hebert-Magee S. The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial. Gastrointest Endosc. 2014 Dec;80(6):1056-63. doi: 10.1016/j.gie.2014.05.304. Epub 2014 Jun 25.
PubMed 24973173
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Evaluating the Number of Passes Required for Diagnostic Cell Block During Endoscopic Ultrasound-Fine Needle Aspiration of Solid Pancreatic Mass Lesions
- ClinicalTrials.gov ID
- NCT01809028
- Acronym / sponsor ID
- 407129
- Conditions
- Pancreatic Cancer
- Keywords
- cell block, number of passes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- University of Alabama at Birmingham
- Study start
- Feb 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 12 Mar 2013 (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.
This study will test the amount of tissue, called "cell block", obtained from your pancreas. Patients who are asked to participate in this study have a growth (mass) in the pancreas that needs a biopsy so a diagnosis can be made. Although we usually perform 2 to 4 passes (number of times the doctor biopsies the mass), at this time we do not know the ideal number of passes needed to obtain adequate amount of tissue for making a diagnosis. The purpose of this study is to compare the amount of tissue obtained with 2 passes versus 4 passes.
Detailed description
Primary Aim:
To compare the number of passes required for obtaining adequate cell block material during EUS-guided FNA of solid pancreatic mass lesions.
Primary Research Hypothesis:
More specimen is required to obtain definitive diagnosis on cell block. This translates to less need for repeat procedures (due to nondiagnostic index procedure due to inadequate FNA passes), prompt treatment to patients and better use of health care resources. Therefore, we will be comparing 2 versus 4 FNA passes to determine which number of FNA pases will yield an adequate diagnostic cell block.
Secondary Aims:
To compare the rate of complications when performing 2 versus 4 EUS-FNA passes of solid pancreatic mass lesions.
Secondary Research Hypothesis:
EUS-guided FNA is a safe procedure with a complication rate of < 1%. By performing more (four) NA passes one is likely to yield a better quality cell block while at the same time without compromising patient safety.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS FNA with 2 passes | Active comparator | Procedure: EUS FNA with 2 passesbiopsy with 2 passes of the needle |
| EUS FNA with 4 passes | Active comparator | Procedure: EUS FNA with 4 passesbiopsy with 4 passes of the needle |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) All patients referred to Florida Hospital Endoscopy Unit for assessment of pancreatic mass lesions that require FNA.
Key exclusion criteria (6 listed)
- Age <19 years
- Unable to safely undergo EUS for any reason
- Coagulopathy (INR >1.6, Prothrombin Time >18secs, Thrombocytopenia <80,000 cells/ml)
- Unable to consent
- Non-English speaking patients.
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 |
|---|---|---|
| EUS FNA with 2 passesAlso: Biopsy, FNAbiopsy with 2 passes | Procedure or surgery | EUS FNA with 2 passes |
| EUS FNA with 4 passesAlso: biopsy, FNAbiopsy with 4 passes | Procedure or surgery | EUS FNA with 4 passes |
Primary outcome
number of passes
Time frame: up to 12 months
The primary endpoint of the study is to compare the number of passes required to make definitive diagnosis on cell block. This will be assessed by amount (quantity) of the sample to make the diagnosis proportionate to which group the subject was randomized to (two passes versus four passes).
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 3 Aug 2017.
- Derived from this study: PubMed 24973173Varadarajulu S, Bang JY, Holt BA, Hasan MK, Logue A, Hawes RH, Hebert-Magee S. The 25-gauge EUS-FNA needle: Good for on-site but poor for off-site evaluation? Results of a randomized trial. Gastrointest Endosc. 2014 Dec;80(6):1056-63. doi: 10.1016/j.gie.2014.05.304. Epub 2014 Jun 25.
- 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 EUS FNA with 2 passes and EUS FNA with 4 passes 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 6 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 3 Aug 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 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?
number of passes (time frame: up to 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 NCT01809028, 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 3 Aug 2017.