Biopsy Protocol of Upper Gastrointestinal Subepithelial Tumors:Diagnostic Accuracy of EUS-FNB Versus Unroofing Biopsy

Study Overview
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Brief Summary
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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.

Conditions
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Upper Gastrointestinal Subepithelial Tumors

Intervention / Treatment
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* Procedure: unroofing biopsy
* Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: unroofing biopsy<br> | Procedure: unroofing biopsy<br>* 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.<br>|
| Active Comparator: EUS-FNB<br> | Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy | We will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result. | within 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications of procedure |  | within 7 days | 
| accuracy of malignant potential on contrast enhanced EUS |  | within 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stomach neoplasm, biopsy