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

NCT02353533 | Unknown

• 1 other identifier: FiRE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Adenoma

Keywords

adenoma; EMR; FTRD; non- lifting; colon

Outcome Measures

Primary Outcomes (1)

• Success of resection

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

  3 month

Secondary Outcomes (1)

• Duration of procedure

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

Study Arms (2)

EMR

OTHER

Standard EMR technique

Device: EMR

FTRD

EXPERIMENTAL

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

Interventions

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

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

FTRD

EMR DEVICE

Standard endoscopic mucosal resection using a resection snare

EMR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (1)

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

Munich, 81675, Germany

RECRUITING

MeSH Terms

Conditions

Adenoma

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Stefan von Delius, MD

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

  STUDY DIRECTOR

Central Study Contacts

Peter Klare, MD

CONTACT

+49 89 4140 2251; peter.klare@lrz.tum.de

Stefan von Delius, MD

CONTACT

+49 89 4140 5975; stefan_ruckert@yahoo.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. med. Peter Klare

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 2, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: November 21, 2016

Record last verified: 2016-11

Locations

DE (1)