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

Primary Purpose

Adenoma

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
over- the- scope full- thickness resection device (FTRD)
EMR
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenoma focused on measuring adenoma, EMR, FTRD, non- lifting, colon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

EMR

FTRD

Arm Description

Standard EMR technique

Outcomes

Primary Outcome Measures

Success of resection
Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment

Secondary Outcome Measures

Duration of procedure

Full Information

First Posted
January 23, 2015
Last Updated
November 18, 2016
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT02353533
Brief Title
Endoscopic Full-thickness REsection of Residual Colorectal Lesions - The FiRE Study
Acronym
FiRE
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Technical University of Munich

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoma
Keywords
adenoma, EMR, FTRD, non- lifting, colon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EMR
Arm Type
Other
Arm Description
Standard EMR technique
Arm Title
FTRD
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
over- the- scope full- thickness resection device (FTRD)
Intervention Description
Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
Intervention Type
Device
Intervention Name(s)
EMR
Intervention Description
Standard endoscopic mucosal resection using a resection snare
Primary Outcome Measure Information:
Title
Success of resection
Description
Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment
Time Frame
3 month
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Klare, MD
Phone
+49 89 4140 2251
Email
peter.klare@lrz.tum.de
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan von Delius, MD
Phone
+49 89 4140 5975
Email
stefan_ruckert@yahoo.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD
Organizational Affiliation
II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany
Official's Role
Study Director
Facility Information:
Facility Name
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München
City
Munich
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
Phone
+49 89 4140 2251
Email
peter.klare@lrz.tum.de
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD
Phone
+49 89 4140 5973
Email
stefan_ruckert@yahoo.de
First Name & Middle Initial & Last Name & Degree
Peter Klare, MD
First Name & Middle Initial & Last Name & Degree
Stefan von Delius, MD

12. IPD Sharing Statement

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

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