Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Adenomas
- Sponsor
- Kliniken Ludwigsburg-Bietigheim gGmbH
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Technical success
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Technical success
Time Frame: Immediate
Successful enbloc- and macroscopically complete resection
R0-Resection
Time Frame: 3 days
Histologically confirmed complete resection
Secondary Outcomes
- Necessity of surgical treatment(3 months)
- Residual or recurrent adenoma/carcinoma at endoscopic follow up(3 months)
- Histologically confirmed full thickness resection(3 days)
- Procedure-associated complications(3 months)
- Procedure time(immediate)