NCT02353533

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Technical University of Munich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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
DEVICE	EMR	Standard endoscopic mucosal resection using a resection snare

Timeline

• Start date: 2015-01-01
• Primary completion: 2017-10-01
• Completion: 2017-12-01
• First posted: 2015-02-02
• Last updated: 2016-11-21

Locations

1 site across 1 country: Germany