Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device" (WALL-RESECT)

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Adenomas; Submucosal Tumors
• Intervention / Treatment: Device: Endoscopic full thickness resection (EFTR)

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Ludwigsburg, Baden-Württemberg, Germany, 71640
      • Recruiting
      • Klinikum Ludwigsburg
      • Contact: Arthur Schmidt, MD; Phone Number: +49-7141-9967201; Email: arthur.schmidt@kliniken-lb.de
      • Contact: Karel Caca, MD, PhD; Phone Number: +49-7141-9967201; Email: karel.caca@kliniken-lb.de
      • Sub-Investigator: Karel Caca, Prof.
      • Principal Investigator: Arthur R Schmidt, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
• Collaborators: Ovesco Endoscopy AG
• Investigators: Study Chair: Karel Caca, MD, PhD, Klinikum Ludwigsburg, Department of Gastroenterology; Principal Investigator: Arthur R Schmidt, MD, Klinikum Ludwigsburg, Department of Gastroenterology

Publications and helpful links

General Publications

• Schurr MO, Baur FE, Krautwald M, Fehlker M, Wehrmann M, Gottwald T, Prosst RL. Endoscopic full-thickness resection and clip defect closure in the colon with the new FTRD system: experimental study. Surg Endosc. 2015 Aug;29(8):2434-41. doi: 10.1007/s00464-014-3923-x. Epub 2014 Oct 16.
• Schmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology. 2014 Oct;147(4):740-742.e2. doi: 10.1053/j.gastro.2014.07.045. Epub 2014 Jul 30. No abstract available.
• Kuellmer A, Behn J, Beyna T, Schumacher B, Meining A, Messmann H, Neuhaus H, Albers D, Birk M, Probst A, Faehndrich M, Frieling T, Goetz M, Thimme R, Caca K, Schmidt A. Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis. BMJ Open Gastroenterol. 2020 Aug;7(1):e000449. doi: 10.1136/bmjgast-2020-000449.
• Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): February 1, 2017

Study Registration Dates

• First Submitted: February 7, 2015
• First Submitted That Met QC Criteria: February 11, 2015
• First Posted (Estimate): February 12, 2015

Study Record Updates

• Last Update Posted (Estimate): February 12, 2015
• Last Update Submitted That Met QC Criteria: February 11, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: EFTR; Endoscopic full thickness resection; FTRD; OTSC
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: WALL-RESECT