Endoscopic Full Thickness Resection With Laparoscopic Ass... | NCT02042079

Studies
Endoscopic Full Thickness Resection With Laparoscopic Assistance

NCT02042079

Sponsor

National Cancer Center, Korea

Status

Unknown status

Last Update Posted

Jan 22, 2014Estimated

Enrollment

15Estimated

Phase

Phase 1

Conditions

Gastric Subepithelial Tumor

Interventions

EFTR with LA

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Mar 2014Estimated

Completion Date

Not provided

First Submitted Date

Jan 19, 2014

First Submission Date that Met QC Criteria

Jan 19, 2014

First Posted Date

Jan 22, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 19, 2014

Last Update Posted Date

Jan 22, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EFTR with LA	Experimental	(Endoscopic full-thickness resection with laparoscopic assistance)	Procedure: EFTR with LA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EFTR with LA	Procedure	(Endoscopic full-thickness resection with laparoscopic assistance)	EFTR with LA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
number of troche		during surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chan G Kim, M.D.	Contact	+82-31-920-1620		glse@chol.com

Overall Officials

Name	Affiliation	Role
Chan G Kim, M.D.	National Cancer Center, Korea	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Cancer Center	Recruiting	Goyang-si	Gyeonggi-do	410-769	South Korea