- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02646241
Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Sevrance Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: unroofing biopsy
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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.
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Active Comparator: EUS-FNB
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
diagnostic accuracy
Time Frame: within 7 days
|
We will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result.
|
within 7 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
number of complications of procedure
Time Frame: within 7 days
|
within 7 days
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accuracy of malignant potential on contrast enhanced EUS
Time Frame: within 7 days
|
within 7 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 4-2015-1033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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