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

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ClinicalTrials.gov Identifier: NCT02657044
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : October 26, 2016
Sponsor:
Collaborator:
Comprehensive Cancer Centre The Netherlands
Information provided by (Responsible Party):
L.M.G. Moons, UMC Utrecht

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 15, 2016
Last Update Posted Date October 26, 2016
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • 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
  • Radical (R0-)resection rate [ Time Frame: within 1 month ]
    Defined as dysplasia free vertical and lateral resection margins at histology
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: January 13, 2016)
  • 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
  • Cost-effectiveness at 36 months [ Time Frame: 36 months ]
    Method of assessment: questionnaire. The cost-effectiveness of ESD against EMR will be performed with the costs per recurrence free patient and the cost per quality adjusted life year (QALY) as outcome measures. QALY will be measured using the EuroQol EQ-5D-5L questionairre.
  • Perceived burden 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: Within 30 days after endoscopic resection ]
    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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EMR Versus ESD for Resection of Large Distal Non-pedunculated Colorectal Adenomas
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Neoplasms
Intervention  ICMJE
  • Procedure: EMR
    Other Name: Endoscopic Mucosal Resection
  • Procedure: ESD
    Other Name: Endoscopic Submucosal Dissection
Study Arms  ICMJE
  • Active Comparator: EMR
    In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
    Intervention: Procedure: EMR
  • Active Comparator: ESD
    In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
    Intervention: Procedure: ESD
Publications * 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, Schröder 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 13, 2016)
212
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Y. Backes, MD 003187550722 y.backes@umcutrecht.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02657044
Other Study ID Numbers  ICMJE 15-610/D
TDM-H1/8051 ( Other Grant/Funding Number: Dutch Cancer Society (DCS) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party L.M.G. Moons, UMC Utrecht
Study Sponsor  ICMJE UMC Utrecht
Collaborators  ICMJE Comprehensive Cancer Centre The Netherlands
Investigators  ICMJE
Principal Investigator: L.M.G. Moons, MD, PhD UMC Utrecht
Principal Investigator: A.D. Koch, MD, PhD Erasmus MC
PRS Account UMC Utrecht
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP