Endoscopic Full Thickness Resection Without Exposure to Peritoneum

National Cancer Center (NCC)

Status and phase: Unknown; Phase 1

Conditions: Submucosal Tumor of Stomach

Treatments: Procedure: simple non-exposure EFTR

Study type: Interventional

Funder types: Other

Identifiers

NCT02764944

NCC2015-0171

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Intervention

Experimental group

Description:

simple non-exposure EFTR group (single arm study)

Treatment:

Procedure: simple non-exposure EFTR