EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02657044|
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Procedure: EMR Procedure: ESD||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||212 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2020|
Active Comparator: EMR
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
Other Name: Endoscopic Mucosal Resection
Active Comparator: ESD
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
Other Name: Endoscopic Submucosal Dissection
- Recurrence rate at follow-up colonoscopy after 6 months [ Time Frame: 6 months ]Observed from resected residual disease or, if not present, from biopsies of the scar
- Long-term recurrence rate at follow-up colonoscopy after 36 months [ Time Frame: 36 months ]Observed from resected residual disease or, if not present, from biopsies of the scar
- Health care resource utilization and consts [ Time Frame: 36 months ]Healthcare costs will be calculated by multiplying used healthcare services with unit prices. The cost-effectiveness of ESD against EMR will be expressed as incremental cost-effectiveness ratios (ICER) showing additional costs per recurrence free patient and as ICER showing additional costs per QALY.
- Perceived burden and quality of life among patients [ Time Frame: 36 months ]Measurement of the patients' burden of ESD versus EMR will be evaluated with regard to colorectal cancer anxiety, burden of the procedure itself, functional complaints and overall quality of life. Meaurement will be performed using validated questionnaires.
- Complication rate [ Time Frame: 30 days ]Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
- Surgical referral rate [ Time Frame: 36 months ]Defined as the number of patients that are referred for surgical management at 36 months
- R0-resection rate [ Time Frame: 30 days ]Defined as dysplasia free vertical and lateral resection margins at histology
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657044
|Contact: Y. Backes, MDfirstname.lastname@example.org|
|Utrecht, Netherlands, 3508GA|
|Contact: Yara Backes, MD +31 88 75 507 22 email@example.com|
|Principal Investigator:||L.M.G. Moons, MD, PhD||UMC Utrecht|
|Principal Investigator:||A.D. Koch, MD, PhD||Erasmus MC|