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

Technical University of Munich

Status: Unknown

Conditions: Adenoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02353533

FiRE

Details and patient eligibility

About

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

EMR

Other group

Description:

Standard EMR technique

Treatment:

Device: EMR

FTRD

Experimental group

Treatment:

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