Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

Pathology Clinical Trial

Official title:

Prospective Study: Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01993199
• Other study ID #: deep biopsy111
• Status: Active, not recruiting
• Phase: N/A
• First received: November 14, 2013
• Last updated: November 19, 2013
• Start date: May 2010
• Est. completion date: December 2015

Study information

• Verified date: November 2013
• Source: Hanyang University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with upper GI SETs

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Benign Neoplasm
• Pathology

Intervention

Procedure:
• deep biopsy via ESD technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of pathologic diagnosis of deep biopsy		within the 7 day	No