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Endoscopic Full Thickness Resection Without Exposure to Peritoneum

Primary Purpose

Submucosal Tumor of Stomach

Status
Unknown status
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
simple non-exposure EFTR
Sponsored by
National Cancer Center, Korea
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Submucosal Tumor of Stomach

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

simple non-exposure EFTR group (single arm study)

Outcomes

Primary Outcome Measures

En bloc resection
rate of en bloc resection (%)

Secondary Outcome Measures

procedure time
minutes
complication
leakage, re-operation, stenosis, etc.
successful closure of resection site
Rate of successful closure (%)

Full Information

First Posted
April 8, 2016
Last Updated
May 4, 2016
Sponsor
National Cancer Center, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02764944
Brief Title
Endoscopic Full Thickness Resection Without Exposure to Peritoneum
Official Title
Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submucosal Tumor of Stomach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
simple non-exposure EFTR group (single arm study)
Intervention Type
Procedure
Intervention Name(s)
simple non-exposure EFTR
Intervention Description
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.
Primary Outcome Measure Information:
Title
En bloc resection
Description
rate of en bloc resection (%)
Time Frame
During operation
Secondary Outcome Measure Information:
Title
procedure time
Description
minutes
Time Frame
During operation
Title
complication
Description
leakage, re-operation, stenosis, etc.
Time Frame
3 months
Title
successful closure of resection site
Description
Rate of successful closure (%)
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chan G Kim, M.D.
Phone
+82-31-920-1620
Email
glse@chol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chan G Kim, M.D.
Organizational Affiliation
National Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center
City
Goyang
State/Province
Gyeonggi
ZIP/Postal Code
410-769
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan G Kim, M.D.
Phone
+82-31-920-1620
Email
glse@chol.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Endoscopic Full Thickness Resection Without Exposure to Peritoneum

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