Endoscopic Full Thickness Resection With Laparoscopic Assistance, Single Center Single Arm Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Gastric Subepithelial Tumor
- Sponsor
- National Cancer Center, Korea
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- En-bloc resection and successful closure
- Last Updated
- 12 years ago
Overview
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.
Investigators
Chan Gyoo Kim
Senior Scientist
National Cancer Center, Korea
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- number of troche(during surgery)