Clinical trial NCT02657044: EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: EMR
ESD
endoscopic mucosal resection
endoscopic submucosal resection
colorectal adenomas
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Comprehensive Cancer Centre The Netherlands
First posted: 2016-01-15
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrence rate at follow-up colonoscopy after 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Long-term recurrence rate at follow-up colonoscopy after 36 months
timeFrame: 36 months
measure: Health care resource utilization and consts
timeFrame: 36 months
measure: Perceived burden and quality of life among patients
timeFrame: 36 months
measure: Complication rate
timeFrame: 30 days
measure: Surgical referral rate
timeFrame: 36 months
measure: R0-resection rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht
name: L.M.G. Moons, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: A.D. Koch, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Backes Y, Moons LM, van Bergeijk JD, Berk L, Ter Borg F, Ter Borg PC, Elias SG, Geesing JM, Groen JN, Hadithi M, Hardwick JC, Kerkhof M, Mangen MJ, Straathof JW, Schroder R, Schwartz MP, Spanier BW, de Vos Tot Nederveen Cappel WH, Wolfhagen FH, Koch AD. Endoscopic mucosal resection (EMR) versus endoscopic submucosal dissection (ESD) for resection of large distal non-pedunculated colorectal adenomas (MATILDA-trial): rationale and design of a multicenter randomized clinical trial. BMC Gastroenterol. 2016 May 26;16(1):56. doi: 10.1186/s12876-016-0468-6.