Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD (RESET)

Kliniken Ludwigsburg-Bietigheim gGmbH

Status: Unknown

Conditions: Feasibility, Complications

Treatments: Device: EFTR

Study type: Observational

Funder types: Other

Identifiers

NCT03096236

RESET

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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