Endoscopic Full Thickness Resection Without Exposure to Peritoneum

May 4, 2016 updated by: Chan Gyoo Kim, National Cancer Center, Korea

Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study

This study evaluates the feasibility of endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) in patients with gastric tumor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Current endoscopic full-thickness resection (EFTR) methods are limited by their transmural communication and exposure of tumor to peritoneum. Recently, endo-laparoscopic full-thickness resection with simple suturing technique which did not expose gastric mucosa to peritoneum (simple non-exposure EFTR) was developed. This new technique includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

This study evaluates the feasibility of simple non-exposure EFTR technique in patients with gastric tumor. This study is single arm study and will be performed in single center.

Study Type

Interventional

Enrollment (Anticipated)

12

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 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
  • Tumor invades of muscularis propria on endoscopic ultrasonography (EUS) finding
  • Tumor size more than 1.5cm or increasing size during observation

Exclusion Criteria:

  • Tumor size more than 5cm
  • Refuse to be enrolled to study.
  • Bleeding tendency,
  • Inappropriate condition for surgery with general anesthesia

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: Intervention
simple non-exposure EFTR group (single arm study)
Procedure: simple non-exposure EFTR
This intervention includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
En bloc resection
Time Frame: During operation
rate of en bloc resection (%)
During operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
procedure time
Time Frame: During operation
minutes
During operation
complication
Time Frame: 3 months
leakage, re-operation, stenosis, etc.
3 months
successful closure of resection site
Time Frame: 1 week
Rate of successful closure (%)
1 week

Collaborators and Investigators

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

Sponsor

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

August 1, 2015

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Estimate)

May 6, 2016

Last Update Submitted That Met QC Criteria

May 4, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC2015-0171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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.

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