Endoscopic Full Thickness Resection Without Exposure to Peritoneum

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Full Thickness Resection Without Exposure to Peritoneum: Single Center Single Arm Study

Conditions
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Submucosal Tumor of Stomach

Intervention / Treatment
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* Procedure: simple non-exposure EFTR


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>simple non-exposure EFTR group (single arm study) | Procedure: simple non-exposure EFTR<br>* This intervention 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| En bloc resection | rate of en bloc resection (%) | During operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure time | minutes | During operation | 
| complication | leakage, re-operation, stenosis, etc. | 3 months | 
| successful closure of resection site | Rate of successful closure (%) | 1 week |