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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02646241
Enrollment
47
Registered
2016-01-05
Start date
2016-01-02
Completion date
2017-06-30
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Gastrointestinal Subepithelial Tumors

Keywords

stomach neoplasm, biopsy

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.

Interventions

PROCEDUREunroofing 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.

PROCEDUREEUS-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by puncutre of a tumor, the tissue whithin the lumen of the fine needle being detached by rotatin, and the needle withdrawn.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.

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
diagnostic accuracywithin 7 daysWe will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result.

Secondary

MeasureTime frame
number of complications of procedurewithin 7 days
accuracy of malignant potential on contrast enhanced EUSwithin 7 days

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026