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

Colorectal Neoplasms Clinical Trial

— MATILDA  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02657044
• Other study ID #: 15-610/D
• Secondary ID: TDM-H1/8051
• Status: Recruiting
• Phase: N/A
• First received: January 8, 2016
• Last updated: October 24, 2016
• Start date: April 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: UMC Utrecht
• Contact: Y. Backes, MD
• Phone: 003187550722
• Email: y.backes[@]umcutrecht.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 212
• Est. completion date: December 2020
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Procedure:
• EMR

• ESD

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Comprehensive Cancer Centre The Netherlands

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Complication rate	Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.	30 days	Yes
Secondary	Surgical referral rate	Defined as the number of patients that are referred for surgical management at 36 months	36 months	Yes
Secondary	R0-resection rate	Defined as dysplasia free vertical and lateral resection margins at histology	30 days	No