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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02646241
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : December 25, 2018
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Upper Gastrointestinal Subepithelial Tumors Procedure: unroofing biopsy Procedure: EUS-FNB(endoscopic ultrasonography guided fine needle biopsy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Actual Study Start Date : January 2, 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: 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.

Primary Outcome Measures :
  1. diagnostic accuracy [ Time Frame: within 7 days ]
    We will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result.

Secondary Outcome Measures :
  1. number of complications of procedure [ Time Frame: within 7 days ]
  2. accuracy of malignant potential on contrast enhanced EUS [ Time Frame: within 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02646241

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Korea, Republic of
Sevrance hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Jun Chul Park, MD    82-2-2228-2272   
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Yonsei University Identifier: NCT02646241     History of Changes
Other Study ID Numbers: 4-2015-1033
First Posted: January 5, 2016    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yonsei University:
stomach neoplasm