Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

November 19, 2013 updated by: Lee Hang Lak, Hanyang University Seoul Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with upper GI SETs

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: deep biopsy
Procedure: deep biopsy via ESD technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the number of pathologic diagnosis of deep biopsy
Time Frame: within the 7 day
within the 7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

November 14, 2013

First Submitted That Met QC Criteria

November 19, 2013

First Posted (ESTIMATE)

November 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 19, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • deep biopsy111

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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