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

NCT02362126 | Unknown

• 1 other identifier: WALL-RESECT
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Adenomas; Submucosal Tumors

Keywords

Endoscopic full thickness resection; EFTR; FTRD; OTSC

Outcome Measures

Primary Outcomes (2)

• Technical success

  Successful enbloc- and macroscopically complete resection

  Immediate

• R0-Resection

  Histologically confirmed complete resection

  3 days

Secondary Outcomes (5)

• Histologically confirmed full thickness resection

  3 days

• Procedure-associated complications

  3 months

• Procedure time

  immediate

• Necessity of surgical treatment

  3 months

• Residual or recurrent adenoma/carcinoma at endoscopic follow up

  3 months

Study Arms (1)

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)

Interventions

Endoscopic full thickness resection (EFTR) DEVICE

Patients undergo EFTR using the FTRD

Patients undergoing EFTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kliniken Ludwigsburg-Bietigheim gGmbH: lead
• Ovesco Endoscopy AG: collaborator

Study Sites (1)

Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, 71640, Germany

RECRUITING

Related Publications (4)

• 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.

  PMID: 25318369 BACKGROUND

• 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.

  PMID: 25083605 BACKGROUND

• 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.

  PMID: 32816955 DERIVED

• 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.

  PMID: 28798042 DERIVED

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Karel Caca, MD, PhD

  Klinikum Ludwigsburg, Department of Gastroenterology

  STUDY CHAIR

• Arthur R Schmidt, MD

  Klinikum Ludwigsburg, Department of Gastroenterology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arthur R Schmidt, MD

CONTACT

0049 (0) 7141 99 67201; arthur.schmidt@kliniken-lb.de

Karel Caca, MD, PhD

CONTACT

0049 (0) 7141 99 67201; karel.caca@kliniken-lb.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2015
• First Posted: February 12, 2015
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

DE (1)