Submucosal Tumor of Stomach
Conditions
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.
Interventions
PROCEDUREsimple non-exposure EFTR
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.
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| En bloc resection | During operation | rate of en bloc resection (%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| procedure time | During operation | minutes |
| complication | 3 months | leakage, re-operation, stenosis, etc. |
| successful closure of resection site | 1 week | Rate of successful closure (%) |
Countries
South Korea
Contacts
Primary ContactChan G Kim, M.D.
Outcome results
None listed