Endoscopic Full Thickness Resection With Laparoscopic Assistance (EFTR-LA)

National Cancer Center (NCC)

Status and phase: Unknown; Phase 1

Conditions: Gastric Subepithelial Tumor

Treatments: Procedure: EFTR with LA

Study type: Interventional

Funder types: Other

Identifiers

NCT02042079

NCCCTS-604

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

EFTR with LA

Experimental group

Description:

(Endoscopic full-thickness resection with laparoscopic assistance)

Treatment:

Procedure: EFTR with LA