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

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Yonsei University

Status

Completed

Conditions

Upper Gastrointestinal Subepithelial Tumors

Treatments

Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)
Procedure: unroofing biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT02646241
4-2015-1033

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

47 participants in 2 patient groups

unroofing biopsy
Experimental group
Treatment:
Procedure: unroofing biopsy
EUS-FNB
Active Comparator group
Treatment:
Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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