Endoscopic Full-thickness REsection of Residual Colorectal Lesions – The FiRE Study

Overview

Adenomatous lesions of the colon are premalignant lesions which have the potential to develop cancer. Therefore adenomas should be resected endoscopically (endo- mucosa resection, EMR). EMR is conducted after submucosal injection of saline which allows to lift the desired lesion prior to resection. In some cases EMR is complicated due to incomplete or failed lifting after the injection of saline. This so- called "non- lifting" sign is a predictor for malignancy of the lesion. Difficult- to- lift polyps are also difficult- to- resect. A higher proportion of these lesions fail to be resected completely using the EMR technique. Alternatively, an over- the- scope full- thickness resection device (FTRD) can be used in order to resect colonic lesions. The FTRD technique has been described elsewhere (Schmidt et al. Gastroenterology 2014; 147: 740-742.e2). No comparative data exists until now on the performance of FTRD resection compared to standard EMR resection of difficult- to- resect colon adenomas. In this study the investigators aim to compare the success of FTRD versus EMR of difficult- to- resect adenomatous lesions (≤ 20 mm).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2017

Interventions

  • Device: over- the- scope full- thickness resection device (FTRD)
    • Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
  • Device: EMR
    • Standard endoscopic mucosal resection using a resection snare

Arms, Groups and Cohorts

  • Other: EMR
    • Standard EMR technique
  • Experimental: FTRD

Clinical Trial Outcome Measures

Primary Measures

  • Success of resection
    • Time Frame: 3 month
    • Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment

Secondary Measures

  • Duration of procedure
    • Time Frame: up to 1 day (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 1 day)

Participating in This Clinical Trial

Inclusion Criteria

  • patients ≥ 18 years – adenomatous lesion 10-20 mm in size with expected difficulties regarding EMR (e.g. "non- lifting sign") Exclusion Criteria:

  • patients < 18 years – lesions > 20 mm in size – high risk carcinomas ("deep submucosal carcinoma") – American Society of Anesthesiologists (ASA) class IV and higher

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Technische Universität München
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr. Peter Klare, Dr. med. Peter Klare – Technische Universität München
  • Overall Official(s)
    • Stefan von Delius, MD, Study Director, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
  • Overall Contact(s)
    • Peter Klare, MD, +49 89 4140 2251, peter.klare@lrz.tum.de

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