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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: Technische Universität München

Current Primary Outcome: Success of resection [ Time Frame: 3 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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) ]

Original Secondary Outcome: Same as current

Information By: Technische Universität München

Dates:
Date Received: January 23, 2015
Date Started: January 2015
Date Completion: December 2017
Last Updated: November 18, 2016
Last Verified: November 2016