Endoscopic Ultrasonography-guided Fine Needle AspirationNCT02977650
EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge
An observational study of Endoscopic Ultrasonography-guided Fine Needle Aspiration, run by Hokkaido Pancreatobiliary Endoscopic Intervention Study Group at 1 site in Japan.
Trial summary
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Endoscopic Ultrasonography-guided Fine Needle Aspiration
- What is being tested?
- Endoscopic ultrasonography-guided fine needle aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2016to Nov 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients taking anticoagulants who underwent EUS-FNA
Who may be able to join
- Taking anticoagulants
- Written informed consent
Who cannot join
- Platelets count less than 50000/μl
- PT-INR more than 2.6
- ASA more than 3
- Severe bleeding tendency
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Hokkaido University Hospital
Sapporo, 0608638
Kazumichi Kawakubo, 117161161, kkawakubo-gi@umin.ac.jp
About this study
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.
- Being tested
- Endoscopic ultrasonography-guided fine needle aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ultrasonography-guided fine needle aspirationProcedure or surgery
Also called EUS-FNA
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of bleeding adverse events
Measured: Within 2 weeks
Secondary outcomes (2)
The rate of thromboembolic events
Measured: Within 2 weeks
The rate of other adverse events
Measured: Within 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Ultrasonography-guided Fine Needle AspirationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Kazumichi Kawakubo, Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977650
- Sponsor's protocol ID
- 016-0040
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-FNA for Patients Taking Anticoagulants Without Heparin Bridge
- ClinicalTrials.gov ID
- NCT02977650
- Acronym / sponsor ID
- 016-0040
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hokkaido Pancreatobiliary Endoscopic Intervention Study GroupResearch network
- Study start
- Nov 2016
- Primary completion
- Nov 2016 (actual)
- First posted
- 30 Nov 2016 (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.
To evaluate the feasibility of EUS-FNA for patients taking anticoagulants without heparin bridge.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients taking anticoagulants who underwent EUS-FNA
Key inclusion criteria (2 listed)
- Taking anticoagulants
- Written informed consent
Key exclusion criteria (4 listed)
- Platelets count less than 50000/μl
- PT-INR more than 2.6
- ASA more than 3
- Severe bleeding tendency
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 ultrasonography-guided fine needle aspirationAlso: EUS-FNA | Procedure or surgery | – |
Primary outcome
The rate of bleeding adverse events
Time frame: Within 2 weeks
2 secondary outcomes
The rate of thromboembolic events
Time frame: Within 2 weeks
The rate of other adverse events
Time frame: Within 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Endoscopic Ultrasonography-guided Fine Needle Aspiration
Recruiting
MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach
Not yet recruiting
22G-Adapt vs 22G-Franseen Needle Biopsy in EUS-Guided Tissue Acquisition of Solid Lesions
Pancreatic Neoplasms, Mediastinal Neoplasms
Recruiting
RCT Comparing Accuracy Among Franseen, Forward-bevel Westcott, and Fork-tip EUS-FNB Needle in Diagnosis of Solid Pancreatic Lesions
Pancreatic Masses
Not yet recruiting
The 22G Trident Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy
Pancreatic Diseases
Not yet recruiting
The 22G Franseen Needle Combined With Different Aspiration Techniques for Endoscopic Ultrasound-guided Fine-needle Biopsy
Pancreatic Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endoscopic Ultrasonography-guided Fine Needle Aspiration, run by Hokkaido Pancreatobiliary Endoscopic Intervention Study Group at 1 site in Japan.
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 4 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: status not confirmed, as of the sponsor's last update on 30 Nov 2016. 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 Japan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kazumichi Kawakubo, Ph.D. (117161161, kkawakubo-gi@umin.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of bleeding adverse events (time frame: Within 2 weeks). 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 30 Nov 2016.