NCT01993199

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 14, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 25, 2013

Status Verified

November 1, 2013

Enrollment Period

2.9 years

First QC Date

November 14, 2013

Last Update Submit

November 19, 2013

Conditions

Benign NeoplasmPathology

Outcome Measures

Primary Outcomes (1)

  • the number of pathologic diagnosis of deep biopsy

    within the 7 day

Study Arms (1)

deep biopsy

ACTIVE COMPARATOR
Procedure: deep biopsy via ESD technique

Interventions

deep biopsy via ESD techniquePROCEDURE
deep biopsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with upper GI SETs

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25111136DERIVED

MeSH Terms

Conditions

Neoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 14, 2013

First Posted

November 25, 2013

Study Start

May 1, 2010

Primary Completion

April 1, 2013

Study Completion

December 1, 2015

Last Updated

November 25, 2013

Record last verified: 2013-11