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

Sponsor

Yonsei University (Other)

Overall Status

Completed

CT.gov ID

NCT02646241

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Subepithelial Tumors	Procedure: unroofing biopsy Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

47 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Actual Study Start Date :

Jan 2, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: unroofing biopsy	Procedure: 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.
Active Comparator: EUS-FNB	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.

Arm

Intervention/Treatment

Experimental: unroofing biopsy

Procedure: 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.

Active Comparator: EUS-FNB

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.

Outcome Measures

Primary Outcome Measures

diagnostic accuracy [within 7 days]
We will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result.

Secondary Outcome Measures

number of complications of procedure [within 7 days]
accuracy of malignant potential on contrast enhanced EUS [within 7 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sevrance hospital	Seoul		Korea, Republic of	120-752

Sponsors and Collaborators

Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yonsei University

ClinicalTrials.gov Identifier:

NCT02646241

Other Study ID Numbers:

4-2015-1033

First Posted:

Jan 5, 2016

Last Update Posted:

Sep 29, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Yonsei University

stomach neoplasm

biopsy

Study Results

No Results Posted as of Sep 29, 2020