Clinical trial NCT02362126: Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"
Official title: Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Adenomas
Submucosal Tumors
Keywords: Endoscopic full thickness resection
EFTR
FTRD
OTSC
Lead sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH
Sponsor class: OTHER
Collaborators: name: Ovesco Endoscopy AG
First posted: 2015-02-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods

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.

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

Primary outcomes:
measure: Technical success
timeFrame: Immediate
measure: R0-Resection
timeFrame: 3 days
Secondary outcomes:
measure: Histologically confirmed full thickness resection
timeFrame: 3 days
measure: Procedure-associated complications
timeFrame: 3 months
measure: Procedure time
timeFrame: immediate
measure: Necessity of surgical treatment
timeFrame: 3 months
measure: Residual or recurrent adenoma/carcinoma at endoscopic follow up
timeFrame: 3 months
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Klinikum Ludwigsburg
state: Baden-Württemberg
Study officials:
affiliation: Klinikum Ludwigsburg, Department of Gastroenterology
name: Karel Caca, MD, PhD
role: STUDY_CHAIR
affiliation: Klinikum Ludwigsburg, Department of Gastroenterology
name: Arthur R Schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.