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Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01993199
Recruitment Status : Unknown
Verified November 2013 by Lee Hang Lak, Hanyang University Seoul Hospital.
Recruitment status was:  Active, not recruiting
First Posted : November 25, 2013
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Lee Hang Lak, Hanyang University Seoul Hospital

Brief Summary:

Upper gastrointestinal subepithelial tumors are frequently encountered during esophagogastroduodenoscopy. Treatment plans for subepithelial tumors are determined by algorithms based on endoscopic ultrasonography images. However, endoscopic ultrasonography alone may not be able to diagnose and evaluate upper gastrointestinal SETs with sufficient accuracy. Adequate tissue samples are required to increase the diagnostic accuracy of subepithelial tumors.

Deep biopsy is method that normal mucosa was dissected using enodsocpi submucosal dissection technique and multiple endoscopic biopsies were performed.

The investigators will perform deep biopsy in subepithelial tumor.


Condition or disease Intervention/treatment Phase
Benign Neoplasm Pathology Procedure: deep biopsy via ESD technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors
Study Start Date : May 2010
Actual Primary Completion Date : April 2013
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Endoscopy

Arm Intervention/treatment
Active Comparator: deep biopsy Procedure: deep biopsy via ESD technique



Primary Outcome Measures :
  1. the number of pathologic diagnosis of deep biopsy [ Time Frame: within the 7 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with upper GI SETs

Exclusion Criteria:

  • none
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lee Hang Lak, Professor, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT01993199    
Other Study ID Numbers: deep biopsy111
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Neoplasms