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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | simple non-exposure EFTR group (single arm study) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| simple non-exposure EFTR | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| En bloc resection | rate of en bloc resection (%) | During operation |
| Measure | Description | Time Frame |
|---|---|---|
| procedure time | minutes | During operation |
| complication | leakage, re-operation, stenosis, etc. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chan G Kim, M.D. | Contact | +82-31-920-1620 | glse@chol.com |
| Name | Affiliation | Role |
|---|---|---|
| Chan G Kim, M.D. | National Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Goyang-si | Gyeonggi-do | 410-769 | South Korea |
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|
| successful closure of resection site | Rate of successful closure (%) | 1 week |