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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endoscopic Full Thickness Resection in the Lower GI Tract With the Full Thickness Resection Device- A Prospective Multicenter Trial

Conditions
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Colorectal Adenomas, Submucosal Tumors

Intervention / Treatment
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* Device: Endoscopic full thickness resection (EFTR)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients undergoing EFTR<br>Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors | Device: Endoscopic full thickness resection (EFTR)<br>* Patients undergo EFTR using the FTRD<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Successful enbloc- and macroscopically complete resection | Immediate | 
| R0-Resection | Histologically confirmed complete resection | 3 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EFTR, Endoscopic full thickness resection, FTRD, OTSC