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

NCT ID: NCT02353533

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Adenoma

Keywords

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adenoma EMR FTRD non- lifting colon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMR

Standard EMR technique

Group Type OTHER

EMR

Intervention Type DEVICE

Standard endoscopic mucosal resection using a resection snare

FTRD

Group Type EXPERIMENTAL

over- the- scope full- thickness resection device (FTRD)

Intervention Type DEVICE

Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device

Interventions

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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

Intervention Type DEVICE

EMR

Standard endoscopic mucosal resection using a resection snare

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technical University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Dr. Peter Klare

Dr. med. Peter Klare

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefan von Delius, MD

Role: STUDY_DIRECTOR

II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Germany

Locations

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II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München

Munich, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Peter Klare, MD

Role: CONTACT

Phone: +49 89 4140 2251

Email: [email protected]

Stefan von Delius, MD

Role: CONTACT

Phone: +49 89 4140 5975

Email: [email protected]

Facility Contacts

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Peter Klare, MD

Role: primary

Stefan von Delius, MD

Role: backup

Other Identifiers

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FiRE

Identifier Type: -

Identifier Source: org_study_id