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

November 18, 2016 updated by: Dr. Peter Klare, Technical University of Munich

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

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

  • Germany
      • Munich, Germany, 81675
        • Recruiting
        • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
        • Principal Investigator:
          • Peter Klare, MD
        • Contact:
        • Contact:

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

Description

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

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

  • Study Director: Stefan von Delius, MD, II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

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

January 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

January 23, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

February 2, 2015

Study Record Updates

Last Update Posted (Estimate)

November 21, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIRE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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