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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

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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasms Procedure: EMR Procedure: ESD Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2016
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: EMR
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
Procedure: EMR
Other Name: Endoscopic Mucosal Resection

Active Comparator: ESD
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
Procedure: ESD
Other Name: Endoscopic Submucosal Dissection




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. Complication rate [ Time Frame: 30 days ]
    Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.

  5. Surgical referral rate [ Time Frame: 36 months ]
    Defined as the number of patients that are referred for surgical management at 36 months

  6. R0-resection rate [ Time Frame: 30 days ]
    Defined as dysplasia free vertical and lateral resection margins at histology



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657044


Contacts
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Contact: Y. Backes, MD 003187550722 y.backes@umcutrecht.nl

Locations
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Netherlands
UMC Utrecht Recruiting
Utrecht, Netherlands, 3508GA
Contact: Yara Backes, MD    +31 88 75 507 22    y.backes@umcutrecht.nl   
Sponsors and Collaborators
UMC Utrecht
Comprehensive Cancer Centre The Netherlands
Investigators
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Principal Investigator: L.M.G. Moons, MD, PhD UMC Utrecht
Principal Investigator: A.D. Koch, MD, PhD Erasmus MC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: L.M.G. Moons, dr. L.M.G. Moons, Principal Investigator, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02657044     History of Changes
Other Study ID Numbers: 15-610/D
TDM-H1/8051 ( Other Grant/Funding Number: Dutch Cancer Society (DCS) )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

Keywords provided by L.M.G. Moons, UMC Utrecht:
EMR
ESD
endoscopic mucosal resection
endoscopic submucosal resection
colorectal adenomas

Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases