Pancreatic CancerNCT02116322
Endoscopic Ultrasound (EUS) Guided Fine Needle Aspiration (FNA) EUS-FNA of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
A study testing EUS-FNA with Corkscrew technique and Expect 19 G Flex needle in people with Pancreatic Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- EUS-FNA with Corkscrew technique and Expect 19 G Flex needle
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)
Who cannot join
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to consent form
- Prior negative FNTA
Show all 9Show fewer
- In situ metallic biliary stents
- Predominantly cystic lesions
- Inaccessible lesions to EUS
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
- Conditions
- Pancreatic Cancer
- Being tested
- EUS-FNA with Corkscrew technique, Expect 19 G Flex needle
- 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 Corkscrew techniqueProcedure or surgery
Expect 19 G Flex needleDevice
Also called Expect 19G Flex needle; Boston scientific
| Study group | Role | What they receive |
|---|---|---|
| Pancreatic mass | Experimental | Patients with pancreatic mass presenting for EUS-FNA Receives: Procedure: EUS-FNA with Corkscrew technique; Device: Expect 19 G Flex needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events as a Measure of Safety
Measured: 30 days
Secondary outcomes (1)
Diagnostic Yield of the FNA Using Corkscrew Technique
Diagnostic yield was defined as the proportion of masses in which the amount of FNA-obtained cellular material was enough for the histopathologist to make the pathological diagnosis.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: The study stopped as the used needle was difficult to maneuver in the corkscrew method being studied so no more participants were included.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mouen A Khashab, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116322
- Sponsor's protocol ID
- NA_00090101
- Status last verified
- May 2017
- First submitted
- 14 Apr 2014
- Last updated
- 24 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Fine Needle Tissue Acquisition of Solid Pancreatic Mass Lesions Using a Novel Corkscrew Technique: a Pilot Study
- ClinicalTrials.gov ID
- NCT02116322
- Acronym / sponsor ID
- NA_00090101
- Conditions
- Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study stopped as the used needle was difficult to maneuver in the corkscrew method being studied so no more participants were included.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Posted 24 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research is being done to investigate if a new technique to biopsy the pancreas will lead to a larger amount tissue material that can be analyzed. Investigators have called the technique the "corkscrew" technique and believe it will allow obtaining a larger biopsy sample during the endoscopic ultrasound examination. The corkscrew technique uses a clockwise rotational movement to drive the needle into the pancreatic mass (like a wine bottle opener twists and buries itself into a cork). It is believed that this will lead to a better biopsy sample than the usual way and therefore result in a higher chance of a diagnosis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pancreatic mass | Experimental | Procedure: EUS-FNA with Corkscrew technique, Device: Expect 19 G Flex needlePatients with pancreatic mass presenting for EUS-FNA |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In-patients and out-patients between the age of 18 and 90 years with solid pancreatic masses presenting for EUS-Fine Needle Aspiration (FNTA)
Key exclusion criteria (9 listed)
- Uncorrectable coagulopathy (INR > 1.5)
- Uncorrectable thrombocytopenia (platelet < 50,000)
- Uncooperative patients
- Pregnant women (women of childbearing age will undergo urine pregnancy testing, which is routine for all endoscopic procedures)
- Refusal to consent form
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 Corkscrew technique | Procedure or surgery | Pancreatic mass |
| Expect 19 G Flex needleAlso: Expect 19G Flex needle; Boston scientific | Device | Pancreatic mass |
Primary outcome
Number of Participants With Adverse Events as a Measure of Safety
Time frame: 30 days
1 secondary outcome
Diagnostic Yield of the FNA Using Corkscrew Technique
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Mouen A Khashab, MD principal investigator
Johns Hopkins University
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 Corkscrew technique and Expect 19 G Flex needle in people with Pancreatic Cancer, run by Johns Hopkins University 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 9 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: stopped early, as of the sponsor's last update on 24 Jul 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?
Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Adverse Events as a Measure of Safety (time frame: 30 days). 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 24 Jul 2017.