EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas — MATILDA  

Colorectal Neoplasms Clinical Trial

Official title: Multicenter, Randomised Controlled Trial Comparing Endoscopic Mucosal Resection (EMR) And Endoscopic Submucosal dissecTIon (ESD) for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA-trial)

Status Recruiting

Clinical Trial Summary

Endoscopic resection of adenomas in the colon is the cornerstone of effective colorectal cancer prevention. Endoscopic mucosal resection (EMR) is currently the most used technique for resection of large distal colorectal adenomas, however, maintains some important limitations. In large lesions, EMR can often only be performed in a piecemeal fashion resulting in relatively low R0-resection rates and high recurrence rates. Endoscopic submucosal dissection (ESD) is a newer procedure that is more difficult resulting in a longer procedural time, but is promising due to the high en-bloc resection rates and the very low recurrence rates. The aim of this multicenter randomized study is to compare EMR and ESD with regard to recurrence rates and radical (R0) resection rates, and to put this into perspective against the costs and complication rates of both strategies and the burden perceived by patients on the long term-term.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoma
• Colorectal Neoplasms

• NCT number: NCT02657044
• Study type: Interventional
• Source: UMC Utrecht
• Contact: Y. Backes, MD
• Phone: 003187550722
• Email: y.backes@umcutrecht.nl
• Status: Recruiting
• Phase: N/A
• Start date: April 2016
• Completion date: December 2020