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

Feasibility, Complications Clinical Trial

— RESET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03096236
• Other study ID #: RESET
• Status: Recruiting
• Phase: N/A
• First received: March 23, 2017
• Last updated: September 15, 2017
• Start date: March 1, 2017
• Est. completion date: September 1, 2019

Study information

• Verified date: September 2017
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Feasibility, Complications

Intervention

Device:
• EFTR
EFTR with the FTRD developed for gastric resection (gFTRD).

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg

Sponsors (1)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Successful enbloc- and macroscopically complete resection	1 minute (immediate)
Secondary	R0-Resection	Histologically confirmed complete resection	three days
Secondary	Histologically confirmed full thickness resection	Histologically confirmed full thickness resection	three days
Secondary	Procedure-associated complications	Procedure-associated complications such as bleeding or perforation	three months
Secondary	Necessity of surgical treatment	Necessity of surgical treatment	three months
Secondary	Residual or recurrent adenoma/carcinoma at endoscopic follow up	Residual or recurrent adenoma/carcinoma at endoscopic follow up	three months