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

• Conditions: Feasibility, Complications

• Registration Number: NCT03096236
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-03-23
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18
• Primary Completion: 2019-03-01
• Study Completion: 2019-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	1 minute (immediate)	Successful enbloc- and macroscopically complete resection

Secondary Outcome Measures

Name	Time	Method
Residual or recurrent adenoma/carcinoma at endoscopic follow up	three months	Residual or recurrent adenoma/carcinoma at endoscopic follow up
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

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Germany