Solid TumorNCT01798654
EUS-FNA for Patients With Antithrombotic Agents
An observational study of Solid Tumor, run by Hokkaido Pancreatobiliary Endoscopic Intervention Study Group at 1 site in Japan.
Trial summary
The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumor
- How many people
- 84 participants
- Where
- 1 siteJapan
- Study dates
- Sep 2012to Sep 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In hospital
Who may be able to join
- Undergo EUS-FNA
- take antithrombotic agents
Who cannot join
- Cystic lesion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Endoscopic Ultrasound-guided Fine Needle Aspiration for Patients With Antithrombotic Agents
The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents.
- Conditions
- Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Antithrombotic agents | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients who suffered bleeding complication
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startSep 2012
- Primary completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
- Sponsor type
- Research network
- Collaborators
- Hokkaido University Hospital
- Responsible party
- Principal investigator, Kazumichi Kawakubo, Hokkaido Pancreatobiliary Endoscopic Intervention Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01798654
- Sponsor's protocol ID
- H-Spirit1201
- Status last verified
- Feb 2016
- First submitted
- 22 Feb 2013
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Endoscopic Ultrasound-guided Fine Needle Aspiration for Patients With Antithrombotic Agents
- ClinicalTrials.gov ID
- NCT01798654
- Acronym / sponsor ID
- H-Spirit1201
- Conditions
- Solid Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Hokkaido Pancreatobiliary Endoscopic Intervention Study GroupResearch network
- Collaborators
- Hokkaido University Hospital
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- First posted
- 26 Feb 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.
The purpose of this study to evaluate a safety of endoscopic ultrasound-guided fine needle aspiration (EUS-FNA) for patients with antithrombotic agents.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antithrombotic agents | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In hospital
Key inclusion criteria (2 listed)
- Undergo EUS-FNA
- take antithrombotic agents
Key exclusion criteria (1 listed)
- Cystic lesion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients who suffered bleeding complication
Time frame: One week
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 19 Feb 2016.
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RecruitingPhase 1/2
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RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
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SW-682 in Advanced Solid Tumors
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RecruitingPhase 1
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Metastatic Malignant Solid Neoplasm, Lymphoma
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.
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 Solid Tumor, 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 1 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 19 Feb 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?
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?
Patients who suffered bleeding complication (time frame: One week). 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 19 Feb 2016.