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

Not Applicable

Completed

• Conditions: Upper Gastrointestinal Subepithelial Tumors
• Interventions: Procedure: unroofing biopsy; Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)

• Registration Number: NCT02646241
• Lead Sponsor: Yonsei University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-01
• Study Start: 2016-01-02
• Study First Submitted QC: 2016-01-04
• Study First Posted: 2016-01-05
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-28
• Last Update Posted: 2020-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
unroofing biopsy	unroofing biopsy	-
EUS-FNB	EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)	-

Primary Outcome Measures

Name	Time	Method
diagnostic accuracy	within 7 days	We will compare between diagnostic accuracy of EUS-FNB \& unroofing biopsy using final histopathological result.

Secondary Outcome Measures

Name	Time	Method
accuracy of malignant potential on contrast enhanced EUS	within 7 days
number of complications of procedure	within 7 days

Trial Locations

Locations (1)

Sevrance hospital; 🇰🇷 Seoul, Korea, Republic of