Endoscopic Full Thickness Resection With Laparoscopic Assistance (EFTR-LA)

January 19, 2014 updated by: Chan Gyoo Kim, National Cancer Center, Korea

Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The laparoscopic resection with a linear stapler for subepithelial tumors (SET) can lead to excessive resection of healthy tissue of the gastric wall resulting in deformity or stenosis. Attaining a positive surgical margin is also possible. Endoscopic full-thickness resection (EFTR) can be used for tumor resection by direct visualization of the tumor from inside the stomach lumen leading to a free surgical margin with little resection of healthy tissue. In order to overcome current endoscopic technical limitations, we will combine the conventional laparoscopic approach with EFTR.

Study Type

Interventional

Enrollment (Anticipated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chan G Kim, M.D.
  • Phone Number: +82-31-920-1620
  • Email: glse@chol.com

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Goyang, Gyeonggi, Korea, Republic of, 410-769
        • Recruiting
        • National Cancer Center
        • Contact:
          • Chan G Kim, M.D.
          • Phone Number: +82-31-920-1620
          • Email: glse@chol.com

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EFTR with LA
(Endoscopic full-thickness resection with laparoscopic assistance)
Procedure: EFTR with LA
(Endoscopic full-thickness resection with laparoscopic assistance)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En-bloc resection and successful closure
Time Frame: 3 months after surgery
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 Outcome Measures

Outcome Measure
Time Frame
number of troche
Time Frame: during surgery
during surgery

Collaborators and Investigators

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

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Chan G Kim, M.D., National Cancer Center, Korea

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

July 1, 2012

Primary Completion (Anticipated)

March 1, 2014

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 19, 2014

First Submitted That Met QC Criteria

January 19, 2014

First Posted (Estimate)

January 22, 2014

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 19, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NCCCTS-604

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

Clinical Trials on Gastric Subepithelial Tumor

Clinical Trials on EFTR with LA

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe