Colorectal Adenomas, Submucosal Tumors
Conditions
Keywords
Endoscopic full thickness resection, EFTR, FTRD, OTSC
Brief summary
Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.
Detailed description
The FTRD (Full Thickness Resection Device, Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract. The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.
Interventions
DEVICEEndoscopic full thickness resection (EFTR)
Patients undergo EFTR using the FTRD
Sponsors
Ovesco Endoscopy AG
Kliniken Ludwigsburg-Bietigheim gGmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 y * Adenoma with negtive lifting sign * Adenoma involving or next to a diverticulum * Adenoma involving or next to the appendical orifice * T1 carcinoma with indication for endoscopic (re-)resection * Subepithelial colorectal tumor with indication for resection
Exclusion criteria
* Lesions \>3 cm * T1 carcinomas with known high-risk features (submucosal infiltration\>1000 um, invasion of lymphatic vessels, poor differentiation (G3)) * Lesions in the upper GI tract * Patients with colorectal stenosis * Patinets not able to undergo informed consent * Pregnancy * Patients with urgent indication for dual thrombocyte aggregation inhibition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success | Immediate | Successful enbloc- and macroscopically complete resection |
| R0-Resection | 3 days | Histologically confirmed complete resection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | immediate | Procedure time |
| Histologically confirmed full thickness resection | 3 days | Histologically confirmed full thickness resection |
| Residual or recurrent adenoma/carcinoma at endoscopic follow up | 3 months | — |
| Necessity of surgical treatment | 3 months | — |
| Procedure-associated complications | 3 months | Procedure-associated complications such as bleeding or perforation |
Countries
Germany
Contacts
Primary ContactArthur R Schmidt, MD
Backup ContactKarel Caca, MD, PhD
Outcome results
None listed