Upper Gastrointestinal Subepithelial TumorsNCT02646241
Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
A study testing unroofing biopsy and EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) in people with Upper Gastrointestinal Subepithelial Tumors, run by Yonsei University at 1 site in South Korea.
Trial summary
To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Upper Gastrointestinal Subepithelial Tumors
- What is being tested?
- unroofing biopsy and EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jan 2016to Jun 2017
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 19 years old and younger than 80 years old
- Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)
Who cannot join
- Patient who had bleeding tendency
- Any previous surgery on esophagus, stomach or duodenum
- Patients who can not be underwent sedated endoscopy
- Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
- Constrast related allergic disease
Trial locations and contacts
1 site in 1 country.
About this study
To increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.
So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.
- Being tested
- unroofing biopsy, EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
- Keywords
- stomach neoplasm, biopsy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unroofing biopsyProcedure or surgery
Unroofing biopsy menas that the mucosa is resected with endoscopic mucosal resection and biopsies are done repeatedly for the exposed tumor with a conventional forcep. It will be performed for the patients with a suspected upper gastrointestinal subepithelial tumor after EUS-FNB. After unroofing biopsy, the final histopathological result will be used to determine diagnostic accuracy.
EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)Procedure or surgery
EUS-FNB will be performed for the same patients who have a gastrointestinal subepithelail tumor before unroofing biopsy. EUS-FNB is called when the tissue is obtained by puncutre of a tumor, the tissue whithin the lumen of the fine needle being detached by rotatin, and the needle withdrawn. The pathological result will be also used to compare diagnostic accuracy between EUS-FNB \& unroofing biopsy.
| Study group | Role | What they receive |
|---|---|---|
| unroofing biopsy | Experimental | Not described Receives: Procedure: unroofing biopsy |
| EUS-FNB | Active comparator | Not described Receives: Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
We will compare between diagnostic accuracy of EUS-FNB \& unroofing biopsy using final histopathological result.
Measured: within 7 days
Secondary outcomes (2)
number of complications of procedure
Measured: within 7 days
accuracy of malignant potential on contrast enhanced EUS
Measured: within 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study start2 Jan 2016
- Primary completionJun 2017
- Study completionJun 2017
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 Upper Gastrointestinal Subepithelial TumorsStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646241
- Sponsor's protocol ID
- 4-2015-1033
- Status last verified
- Sep 2020
- First submitted
- 1 Jan 2016
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Park J, Park JC, Jo JH, Kim EH, Shin SK, Lee SK, Lee YC. Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy. Dig Liver Dis. 2019 Jun;51(6):831-836. doi: 10.1016/j.dld.2019.01.028. Epub 2019 Feb 19.
PubMed 30872087
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
- ClinicalTrials.gov ID
- NCT02646241
- Acronym / sponsor ID
- 4-2015-1033
- Keywords
- stomach neoplasm, biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 5 Jan 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 increase the diagnostic accuracy of subepithelial tumors, larger tissue samples are required. It is difficult to obtain adequate tissue samples. There were several biopsy methods to obtain tissue samples. Pathological examination would include mitosis counts, particularly in hypoechoic subepithelial tumors located in the 4th layer of the gastric wall, where differentiation between leiomyoma of benign nature and gastrointestinal stromal tumor (GIST) of malignant potential is essential.
So We hypothesize that unroofing biopsy is an more appropriate method than EUS-FNB(endoscopic ultrasonography guided fine needle biopsy). We will compare diagnostic accuracy and complications between EUS-FNB \& unroofing biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unroofing biopsy | Experimental | Procedure: unroofing biopsy |
| EUS-FNB | Active comparator | Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older than 19 years old and younger than 80 years old
- Suspected upper gastrointestinal subepithelial tumors(≥15mm, ≤35mm) that were originated from muscularis propria layer on endoscopic ultrasonography(EUS)
Key exclusion criteria (5 listed)
- Patient who had bleeding tendency
- Any previous surgery on esophagus, stomach or duodenum
- Patients who can not be underwent sedated endoscopy
- Gastrointestinal subepithelial tumor that was not origianted from muscularis propria layer on EUS
- Constrast related allergic disease
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 |
|---|---|---|
| unroofing biopsyUnroofing biopsy menas that the mucosa is resected with endoscopic mucosal resection and biopsies are done repeatedly for the exposed tumor with a conventional forcep. It will be performed for the patients with a suspected upper gastrointestinal subepithelial tumor after EUS-FNB. After unroofing biopsy, the final histopathological result will be used to determine diagnostic accuracy. | Procedure or surgery | unroofing biopsy |
| EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)EUS-FNB will be performed for the same patients who have a gastrointestinal subepithelail tumor before unroofing biopsy. EUS-FNB is called when the tissue is obtained by puncutre of a tumor, the tissue whithin the lumen of the fine needle being detached by rotatin, and the needle withdrawn. The pathological result will be also used to compare diagnostic accuracy between EUS-FNB \& unroofing biopsy. | Procedure or surgery | EUS-FNB |
Primary outcome
diagnostic accuracy
Time frame: within 7 days
We will compare between diagnostic accuracy of EUS-FNB \& unroofing biopsy using final histopathological result.
2 secondary outcomes
number of complications of procedure
Time frame: within 7 days
accuracy of malignant potential on contrast enhanced EUS
Time frame: within 7 days
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 29 Sep 2020.
- Derived from this study: PubMed 30872087Park J, Park JC, Jo JH, Kim EH, Shin SK, Lee SK, Lee YC. Prospective comparative study of endoscopic ultrasonography-guided fine-needle biopsy and unroofing biopsy. Dig Liver Dis. 2019 Jun;51(6):831-836. doi: 10.1016/j.dld.2019.01.028. Epub 2019 Feb 19.
- Individual participant dataSharing planned: No
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?
A study testing unroofing biopsy and EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) in people with Upper Gastrointestinal Subepithelial Tumors, run by Yonsei University at 1 site in South Korea.
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 5 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 29 Sep 2020. 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 South Korea. 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?
diagnostic accuracy (time frame: within 7 days). 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 NCT02646241, 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 29 Sep 2020.