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

Not Applicable

• Conditions: Adenoma
• Interventions: Device: EMR; Device: over- the- scope full- thickness resection device (FTRD)

• Registration Number: NCT02353533
• Lead Sponsor: Technical University of Munich

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-23
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-02-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMR	EMR	Standard EMR technique
FTRD	over- the- scope full- thickness resection device (FTRD)	-

Primary Outcome Measures

Name	Time	Method
Success of resection	3 month	Success of resection: Complete resection (R0) according to clinical and/or histopathological assessment

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München; 🇩🇪 Munich, Germany