Benign NeoplasmNCT01993199
Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
A study testing deep biopsy via ESD technique in people with Benign Neoplasm and Pathology, run by Hanyang University Seoul Hospital.
Trial summary
Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Benign Neoplasm, Pathology
- What is being tested?
- deep biopsy via ESD technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- May 2010to Dec 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with upper GI SETs
Who cannot join
- none
About this study
Official title: Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors.
Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed.
The investigators will perform deep biopsy in subepithelial tumor.
- Conditions
- Benign Neoplasm, Pathology
- Being tested
- deep biopsy via ESD technique
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep biopsy via ESD techniqueProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| deep biopsy | Active comparator | Not described Receives: Procedure: deep biopsy via ESD technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
the number of pathologic diagnosis of deep biopsy
Measured: within the 7 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startMay 2010
- Primary completionApr 2013
- Study completionDec 2015 (estimated)
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 Benign NeoplasmStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Hang Lak, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993199
- Sponsor's protocol ID
- deep biopsy111
- Status last verified
- Nov 2013
- First submitted
- 14 Nov 2013
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Tae HJ, Lee HL, Lee KN, Jun DW, Lee OY, Han DS, Yoon BC, Choi HS, Hahm JS. Deep biopsy via endoscopic submucosal dissection in upper gastrointestinal subepithelial tumors: a prospective study. Endoscopy. 2014 Oct;46(10):845-50. doi: 10.1055/s-0034-1377627. Epub 2014 Aug 11.
PubMed 25111136
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
- ClinicalTrials.gov ID
- NCT01993199
- Acronym / sponsor ID
- deep biopsy111
- Conditions
- Benign Neoplasm, Pathology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 25 Nov 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.
Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors.
Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed.
The investigators will perform deep biopsy in subepithelial tumor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| deep biopsy | Active comparator | Procedure: deep biopsy via ESD technique |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with upper GI SETs
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| deep biopsy via ESD technique | Procedure or surgery | deep biopsy |
Primary outcome
the number of pathologic diagnosis of deep biopsy
Time frame: within the 7 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
- Derived from this study: PubMed 25111136Tae HJ, Lee HL, Lee KN, Jun DW, Lee OY, Han DS, Yoon BC, Choi HS, Hahm JS. Deep biopsy via endoscopic submucosal dissection in upper gastrointestinal subepithelial tumors: a prospective study. Endoscopy. 2014 Oct;46(10):845-50. doi: 10.1055/s-0034-1377627. Epub 2014 Aug 11.
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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 deep biopsy via ESD technique in people with Benign Neoplasm and Pathology, run by Hanyang University Seoul Hospital.
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 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: status not confirmed, as of the sponsor's last update on 25 Nov 2013. 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?
Results are not available in the source record.
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?
the number of pathologic diagnosis of deep biopsy (time frame: within the 7 day). 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 NCT01993199, 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 25 Nov 2013.