Deep Biopsy Via Endoscopic Submucosal Dissection in Upper... | NCT01993199

Studies
Deep Biopsy Via Endoscopic Submucosal Dissection in Upper GI Subepithelial Tumors

NCT01993199

Sponsor

Hanyang University Seoul Hospital

Status

Unknown status

Last Update Posted

Nov 25, 2013Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Benign Neoplasm
Pathology

Interventions

deep biopsy via ESD technique

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Apr 2013Actual

Completion Date

Dec 2015Estimated

First Submitted Date

Nov 14, 2013

First Submission Date that Met QC Criteria

Nov 19, 2013

First Posted Date

Nov 25, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2013

Last Update Posted Date

Nov 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lee Hang Lak, Professor, Hanyang University Seoul HospitalPrincipal Investigator

Lead Sponsor

Hanyang University Seoul HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Label	Type	Description	Intervention Names
deep biopsy	Active Comparator		Procedure: deep biopsy via ESD technique

Name	Type	Description	Arm Group Labels	Other Names
deep biopsy via ESD technique	Procedure		deep biopsy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with upper GI SETs

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25111136	Derived	Tae HJ, Lee HL, Lee KN, Jun DW, Lee OY, Han DS, Yoon BC, Choi HS, Hahm JS. Deep biopsy via endoscopic submucosal dissection in upper gastrointestinal subepithelial tumors: a prospective study. Endoscopy. 2014 Oct;46(10):845-50. doi: 10.1055/s-0034-1377627. Epub 2014 Aug 11.