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

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Procedure: EMR
* Procedure: ESD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-pedunculated polyp larger than 20 mm in the rectum, sigmoid or descending colon found during colonoscopy indication for endoscopic treatment ≥18 years old Written informed consent Exclusion Criteria: suspicion of malignancy, as determined by endoscopic findings (invasive Kudo pit pattern, Hiroshima type C) or proven malignancy at histology prior endoscopic resection attempt presence of synchronous distal advanced carcinoma that requires surgical resection the risk exceeds the benefit of endoscopic treatment, such as patient's with an extremely poor general condition or a very short life expectancy the inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EMR<br>In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique. | Procedure: EMR<br> <br> * Other names: Endoscopic Mucosal Resection;|
| Active Comparator: ESD<br>In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique. | Procedure: ESD<br> <br> * Other names: Endoscopic Submucosal Dissection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence rate at follow-up colonoscopy after 6 months | Observed from resected residual disease or, if not present, from biopsies of the scar | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term recurrence rate at follow-up colonoscopy after 36 months | Observed from resected residual disease or, if not present, from biopsies of the scar | 36 months | 
| Health care resource utilization and consts | 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. | 36 months | 
| Perceived burden and quality of life among patients | 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. | 36 months | 
| Complication rate | Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis. | 30 days | 
| Surgical referral rate | Defined as the number of patients that are referred for surgical management at 36 months | 36 months | 
| R0-resection rate | Defined as dysplasia free vertical and lateral resection margins at histology | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EMR, ESD, endoscopic mucosal resection, endoscopic submucosal resection, colorectal adenomas