Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
RESET
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Mar 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 23, 2017
CompletedFirst Posted
Study publicly available on registry
March 30, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2019
CompletedSeptember 18, 2017
September 1, 2017
2 years
March 23, 2017
September 15, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Technical success
Successful enbloc- and macroscopically complete resection
1 minute (immediate)
Secondary Outcomes (5)
R0-Resection
three days
Histologically confirmed full thickness resection
three days
Procedure-associated complications
three months
Necessity of surgical treatment
three months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
three months
Interventions
EFTR with the FTRD developed for gastric resection (gFTRD).
Eligibility Criteria
Patients with gastric SET
You may qualify if:
- Age \> 18 years
- Gastric SET up to 15 mm (measurement: endoscopic ultrasound)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinikum Ludwigsburg
Ludwigsburg, Germany
Related Publications (1)
Meier 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: 31187233DERIVED
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2017
First Posted
March 30, 2017
Study Start
March 1, 2017
Primary Completion
March 1, 2019
Study Completion
September 1, 2019
Last Updated
September 18, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share