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

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ClinicalTrials.gov Identifier: NCT02353533
Recruitment Status : Recruiting
First Posted : February 2, 2015
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Peter Klare, Technische Universität München

Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Adenoma Device: over- the- scope full- thickness resection device (FTRD) Device: EMR Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
EMR
Standard EMR technique
Device: EMR
Standard endoscopic mucosal resection using a resection snare

Experimental: FTRD 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




Primary Outcome Measures :
  1. Success of resection [ Time Frame: 3 month ]
    Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment


Secondary Outcome Measures :
  1. 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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02353533


Contacts
Contact: Peter Klare, MD +49 89 4140 2251 peter.klare@lrz.tum.de
Contact: Stefan von Delius, MD +49 89 4140 5975 stefan_ruckert@yahoo.de

Locations
Germany
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München Recruiting
Munich, Germany, 81675
Contact: Peter Klare, MD    +49 89 4140 2251    peter.klare@lrz.tum.de   
Contact: Stefan von Delius, MD    +49 89 4140 5973    stefan_ruckert@yahoo.de   
Principal Investigator: Peter Klare, MD         
Principal Investigator: Stefan von Delius, MD         
Sponsors and Collaborators
Technische Universität München
Investigators
Study Director: Stefan von Delius, MD II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

Responsible Party: Dr. Peter Klare, Dr. med. Peter Klare, Technische Universität München
ClinicalTrials.gov Identifier: NCT02353533     History of Changes
Other Study ID Numbers: FiRE
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016

Keywords provided by Dr. Peter Klare, Technische Universität München:
adenoma
EMR
FTRD
non- lifting
colon

Additional relevant MeSH terms:
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms