Trials / Unknown
UnknownNCT02657044
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
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
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 212 (estimated)
- Sponsor
- UMC Utrecht · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | EMR | |
| PROCEDURE | ESD |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2018-09-01
- Completion
- 2020-12-01
- First posted
- 2016-01-15
- Last updated
- 2016-10-26
Locations
1 site across 1 country: Netherlands
Source: ClinicalTrials.gov record NCT02657044. Inclusion in this directory is not an endorsement.