NCT02042079

Brief Summary

The purpose of this study is to evaluate the feasibility of endoscopic full-thickness resection with laparoscopic assistance.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1

Geographic Reach
1 country

1 active site

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

July 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

January 19, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

1.7 years

First QC Date

January 19, 2014

Last Update Submit

January 19, 2014

Conditions

Gastric Subepithelial Tumor

Keywords

Endoscopic full-thickness resectiongastric subepithelial tumorhybrid-NOTES

Outcome Measures

Primary Outcomes (1)

  • En-bloc resection and successful closure

    successful En-bloc resection of subepithelial tumor and successful closure of resection site by Endoscopic full-thickness resection with laparoscopic assistance.

    3 months after surgery

Secondary Outcomes (1)

  • number of troche

    during surgery

Study Arms (1)

EFTR with LA

EXPERIMENTAL

(Endoscopic full-thickness resection with laparoscopic assistance)

Procedure: EFTR with LA

Interventions

EFTR with LAPROCEDURE

(Endoscopic full-thickness resection with laparoscopic assistance)

EFTR with LA

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gastric subepithelial tumor
  • Invasion of muscularis propria on Endoscopic ultrasound
  • Tumor size 1.5cm-5cm or increasing size during follow-up

You may not qualify if:

  • Bleeding tendency,
  • Inappropriate condition for surgery with general anesthesia
  • Refuse to be enrolled to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

RECRUITING

Study Officials

  • Chan G Kim, M.D.

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan G Kim, M.D.

CONTACT

+82-31-920-1620glse@chol.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

January 19, 2014

First Posted

January 22, 2014

Study Start

July 1, 2012

Primary Completion

March 1, 2014

Last Updated

January 22, 2014

Record last verified: 2014-01

Locations

KR(1)