Clinical trial · Observational
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Feasibility, Complications | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EFTR | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Technical success
- timeFrame
- 1 minute (immediate)
- description
- Successful enbloc- and macroscopically complete resection
Secondary outcomes (5)
- measure
- R0-Resection
- timeFrame
- three days
- description
- Histologically confirmed complete resection
- measure
- Histologically confirmed full thickness resection
- timeFrame
- three days
- description
- Histologically confirmed full thickness resection
- measure
- Procedure-associated complications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDMeier 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. PMID 31187233