Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

• Conditions: Colorectal Adenomas; Submucosal Tumors

• Registration Number: NCT02362126
• Lead Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

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.

Study Timeline

• Status Verified: 2015-02
• Study Start: 2015-02
• Study First Submitted: 2015-02-07
• Study First Submitted QC: 2015-02-11
• Last Update Submitted: 2015-02-11
• Study First Posted: 2015-02-12
• Last Update Posted: 2015-02-12
• Primary Completion: 2017-02
• Study Completion: 2017-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical success	Immediate	Successful enbloc- and macroscopically complete resection
R0-Resection	3 days	Histologically confirmed complete resection

Secondary Outcome Measures

Name	Time	Method
Necessity of surgical treatment	3 months
Residual or recurrent adenoma/carcinoma at endoscopic follow up	3 months
Histologically confirmed full thickness resection	3 days	Histologically confirmed full thickness resection
Procedure-associated complications	3 months	Procedure-associated complications such as bleeding or perforation
Procedure time	immediate	Procedure time

Trial Locations

Locations (1)

Klinikum Ludwigsburg; 🇩🇪 Ludwigsburg, Baden-Württemberg, Germany