Endoscopic Full Thickness Resection With Laparoscopic Assistance

Phase 1

• Conditions: Gastric Subepithelial Tumor
• Interventions: Procedure: EFTR with LA

• Registration Number: NCT02042079
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2012-07
• Status Verified: 2014-01
• Study First Submitted: 2014-01-19
• Study First Submitted QC: 2014-01-19
• Last Update Submitted: 2014-01-19
• Study First Posted: 2014-01-22
• Last Update Posted: 2014-01-22
• Primary Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EFTR with LA	EFTR with LA	(Endoscopic full-thickness resection with laparoscopic assistance)

Primary Outcome Measures

Name	Time	Method
En-bloc resection and successful closure	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.

Secondary Outcome Measures

Name	Time	Method
number of troche	during surgery

Trial Locations

Locations (1)

National Cancer Center; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of