Endoscopic Full Thickness Resection Without Exposure to Peritoneum

Phase 1

• Conditions: Submucosal Tumor of Stomach
• Interventions: Procedure: simple non-exposure EFTR

• Registration Number: NCT02764944
• Lead Sponsor: National Cancer Center, Korea

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-08
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-06
• Last Update Posted: 2016-05-06
• Primary Completion: 2016-12
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	simple non-exposure EFTR	simple non-exposure EFTR group (single arm study)

Primary Outcome Measures

Name	Time	Method
En bloc resection	During operation	rate of en bloc resection (%)

Secondary Outcome Measures

Name	Time	Method
procedure time	During operation	minutes
successful closure of resection site	1 week	Rate of successful closure (%)
complication	3 months	leakage, re-operation, stenosis, etc.

Trial Locations

Locations (1)

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