Gastrointestinal Subepithelial TumorsNCT02943837
EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
A study testing Device: 22G FNA needle and Device: 20G FNB needle in people with Gastrointestinal Subepithelial Tumors, run by Asan Medical Center.
Trial summary
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Gastrointestinal Subepithelial Tumors
- What is being tested?
- Device: 22G FNA needle and Device: 20G FNB needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2016to 1 Dec 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Esophageal, gastric, or duodenal SET over 2 cm
- Hypoechoic lesion including 4th layer on EUS
Who cannot join
- SET with characteristic findings such as lipoma, vessels, or ectopic pancreas
- bleeding or rupture of SET
- platelet count <50,000 or prothrombin time INR > 1.3
About this study
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.
Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.
- Conditions
- Gastrointestinal Subepithelial Tumors
- Being tested
- Device: 22G FNA needle, Device: 20G FNB needle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: 22G FNA needleProcedure or surgery
Device: 20G FNB needleProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EUS-FNA | Active comparator | Device: 22G FNA needle Receives: Procedure: Device: 22G FNA needle |
| EUS-FNB | Experimental | Device: 20G FNB needle Receives: Procedure: Device: 20G FNB needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
Gold standard diagnosis is defined as;
- in operated patients; histological assessment of the surgical resection specimen
- in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study start1 Oct 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: Funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Subepithelial TumorsStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kee Don Choi, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943837
- Sponsor's protocol ID
- AMCSMT 001
- Status last verified
- Jan 2021
- First submitted
- 20 Oct 2016
- Last updated
- 13 Jan 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors
- ClinicalTrials.gov ID
- NCT02943837
- Acronym / sponsor ID
- AMCSMT 001
- Conditions
- Gastrointestinal Subepithelial Tumors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 25 Oct 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.
Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.
Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EUS-FNA | Active comparator | Procedure: Device: 22G FNA needleDevice: 22G FNA needle |
| EUS-FNB | Experimental | Procedure: Device: 20G FNB needleDevice: 20G FNB needle |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Esophageal, gastric, or duodenal SET over 2 cm
- Hypoechoic lesion including 4th layer on EUS
Key exclusion criteria (3 listed)
- SET with characteristic findings such as lipoma, vessels, or ectopic pancreas
- bleeding or rupture of SET
- platelet count <50,000 or prothrombin time INR > 1.3
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 |
|---|---|---|
| Device: 22G FNA needle | Procedure or surgery | EUS-FNA |
| Device: 20G FNB needle | Procedure or surgery | EUS-FNB |
Primary outcome
Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis
Time frame: 12 months
Gold standard diagnosis is defined as; 1. in operated patients; histological assessment of the surgical resection specimen 2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)
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 13 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Device: 22G FNA needle and Device: 20G FNB needle in people with Gastrointestinal Subepithelial Tumors, run by Asan Medical Center.
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 3 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Diagnostic accuracy (proportion of correctly classified subjects (ture positive + true negative) among all subjects ) , compared to the gold standard diagnosis (time frame: 12 months). 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 13 Jan 2021.