Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

• Sponsor: Hanyang University Seoul Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01993199
• Collaborator: (none)
• Enrollment: 40
• Arm: 1
• Duration (Months): 67

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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 1, 2010
• Actual Primary Completion Date: Apr 1, 2013
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the number of pathologic diagnosis of deep biopsy [within the 7 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients with upper GI SETs

Exclusion Criteria:

• none

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hanyang University Seoul Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lee Hang Lak, Professor, Hanyang University Seoul Hospital
• ClinicalTrials.gov Identifier: NCT01993199
• Other Study ID Numbers: deep biopsy111
• First Posted: Nov 25, 2013
• Last Update Posted: Nov 25, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Nov 25, 2013