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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-02

Study Completion Date

2017-06-30

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.

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Detailed Description

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Conditions

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Upper Gastrointestinal Subepithelial Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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unroofing biopsy

Group Type EXPERIMENTAL

unroofing biopsy

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)

Intervention Type PROCEDURE

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.

Interventions

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unroofing biopsy

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

Minimum Eligible Age

19 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No