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.|
|ClinicalTrials.gov Identifier: NCT02646241|
Recruitment Status : Recruiting
First Posted : January 5, 2016
Last Update Posted : December 25, 2018
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||January 2, 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
|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.
- diagnostic accuracy [ Time Frame: within 7 days ]We will compare between diagnostic accuracy of EUS-FNB & unroofing biopsy using final histopathological result.
- number of complications of procedure [ Time Frame: within 7 days ]
- accuracy of malignant potential on contrast enhanced EUS [ Time Frame: within 7 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT02646241
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|
|Contact: Jun Chul Park, MD 82-2-2228-2272 firstname.lastname@example.org|