Feasibility, Complications
Conditions
Brief summary
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.
Interventions
DEVICEEFTR
EFTR with the FTRD developed for gastric resection (gFTRD).
Sponsors
Kliniken Ludwigsburg-Bietigheim gGmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Gastric SET up to 15 mm (measurement: endoscopic ultrasound)
Exclusion criteria
* Age \< 18 years * Gastric SET \> 15 mm and/or large extramural part * Criteria of Lipoma (endoscopic ultrasound) * Positive lymph nodes (endoscopic ultrasound) * Stenosis (Esophagus) * Diverticulum (Esophagus) * Pregnancy or Nursing period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | 1 minute (immediate) | Successful enbloc- and macroscopically complete resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| R0-Resection | three days | Histologically confirmed complete resection |
| Histologically confirmed full thickness resection | three days | Histologically confirmed full thickness resection |
| Procedure-associated complications | three months | Procedure-associated complications such as bleeding or perforation |
| Necessity of surgical treatment | three months | Necessity of surgical treatment |
| Residual or recurrent adenoma/carcinoma at endoscopic follow up | three months | Residual or recurrent adenoma/carcinoma at endoscopic follow up |
Countries
Germany
Outcome results
None listed