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Subepithelial gastric tumors are rare and usually detected incidentally. Most subepithelial tumors (SET) are benign but up to 13% of all lesions can be malignant. Histology after needle biopsy often brings no clear diagnosis in SET, so further strategy often remains unclear. Surveillance endoscopy can be associated with the risk of progression. Endoscopic resection usually is difficult, associated with high risk of complications and sometimes is not feasible. Surgical resection is also associated with a risk of complications and often refused by the patients. With the developement of the gFTRD-System gastric SET can now be resected endoscopically. The advantage of this technique is the complete resection and a full-thickness resections specimen for are definite histology.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EFTR | Device | EFTR with the FTRD developed for gastric resection (gFTRD). |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Successful enbloc- and macroscopically complete resection | 1 minute (immediate) |
| Measure | Description | Time Frame |
|---|---|---|
| R0-Resection | Histologically confirmed complete resection | three days |
| Histologically confirmed full thickness resection | Histologically confirmed full thickness resection |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with gastric SET
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Recruiting | Ludwigsburg | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31187233 | Derived | Meier B, Schmidt A, Glaser N, Meining A, Walter B, Wannhoff A, Riecken B, Caca K. Endoscopic full-thickness resection of gastric subepithelial tumors with the gFTRD-system: a prospective pilot study (RESET trial). Surg Endosc. 2020 Feb;34(2):853-860. doi: 10.1007/s00464-019-06839-2. Epub 2019 Jun 11. |
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| three days |
| Procedure-associated complications | Procedure-associated complications such as bleeding or perforation | three months |
| Necessity of surgical treatment | Necessity of surgical treatment | three months |
| Residual or recurrent adenoma/carcinoma at endoscopic follow up | Residual or recurrent adenoma/carcinoma at endoscopic follow up | three months |