Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device" (WALL-RESECT)
February 11, 2015 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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
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Sub-Investigator:
- Karel Caca, Prof.
-
Principal Investigator:
- Arthur R Schmidt, Dr.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
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
|
Patients undergo EFTR using the FTRD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Technical success
Time Frame: Immediate
|
Successful enbloc- and macroscopically complete resection
|
Immediate
|
|
R0-Resection
Time Frame: 3 days
|
Histologically confirmed complete resection
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Histologically confirmed full thickness resection
Time Frame: 3 days
|
Histologically confirmed full thickness resection
|
3 days
|
|
Procedure-associated complications
Time Frame: 3 months
|
Procedure-associated complications such as bleeding or perforation
|
3 months
|
|
Procedure time
Time Frame: immediate
|
Procedure time
|
immediate
|
|
Necessity of surgical treatment
Time Frame: 3 months
|
3 months
|
|
|
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
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
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- WALL-RESECT
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