EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas (MATILDA)
Primary Purpose
Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
EMR
ESD
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Neoplasms focused on measuring EMR, ESD, endoscopic mucosal resection, endoscopic submucosal resection, colorectal adenomas
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
Sites / Locations
- UMC UtrechtRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
EMR
ESD
Arm Description
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
Outcomes
Primary Outcome Measures
Recurrence rate at follow-up colonoscopy after 6 months
Observed from resected residual disease or, if not present, from biopsies of the scar
Secondary Outcome Measures
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
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.
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.
Complication rate
Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
Surgical referral rate
Defined as the number of patients that are referred for surgical management at 36 months
R0-resection rate
Defined as dysplasia free vertical and lateral resection margins at histology
Full Information
NCT ID
NCT02657044
First Posted
January 8, 2016
Last Updated
October 24, 2016
Sponsor
UMC Utrecht
Collaborators
Comprehensive Cancer Centre The Netherlands
1. Study Identification
Unique Protocol Identification Number
NCT02657044
Brief Title
EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
Comprehensive Cancer Centre The Netherlands
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
EMR, ESD, endoscopic mucosal resection, endoscopic submucosal resection, colorectal adenomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
212 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EMR
Arm Type
Active Comparator
Arm Description
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
Arm Title
ESD
Arm Type
Active Comparator
Arm Description
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
Intervention Type
Procedure
Intervention Name(s)
EMR
Other Intervention Name(s)
Endoscopic Mucosal Resection
Intervention Type
Procedure
Intervention Name(s)
ESD
Other Intervention Name(s)
Endoscopic Submucosal Dissection
Primary Outcome Measure Information:
Title
Recurrence rate at follow-up colonoscopy after 6 months
Description
Observed from resected residual disease or, if not present, from biopsies of the scar
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Long-term recurrence rate at follow-up colonoscopy after 36 months
Description
Observed from resected residual disease or, if not present, from biopsies of the scar
Time Frame
36 months
Title
Health care resource utilization and consts
Description
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.
Time Frame
36 months
Title
Perceived burden and quality of life among patients
Description
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.
Time Frame
36 months
Title
Complication rate
Description
Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
Time Frame
30 days
Title
Surgical referral rate
Description
Defined as the number of patients that are referred for surgical management at 36 months
Time Frame
36 months
Title
R0-resection rate
Description
Defined as dysplasia free vertical and lateral resection margins at histology
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Y. Backes, MD
Phone
003187550722
Email
y.backes@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
L.M.G. Moons, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A.D. Koch, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3508GA
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yara Backes, MD
Phone
+31 88 75 507 22
Email
y.backes@umcutrecht.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
27229709
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.
Results Reference
derived
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EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
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