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

October 24, 2016 updated by: L.M.G. Moons, UMC Utrecht

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: EMR
In the EMR-arm, endoscopic resection will be performed using the (p)EMR technique.
Procedure: EMR
Other Names:
  • Endoscopic Mucosal Resection
Active Comparator: ESD
In the ESD-arm, endoscopic resection will be performed using the (h)ESD technique.
Procedure: ESD
Other Names:
  • Endoscopic Submucosal Dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
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.
36 months
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.
36 months
Complication rate
Time Frame: 30 days
Complications will be assessed on day 30: intraprocedural perforation, Intraprocedural bleeding, Postprocedural bleeding, Postprocedural perforation, Postprocedural serositis.
30 days
Surgical referral rate
Time Frame: 36 months
Defined as the number of patients that are referred for surgical management at 36 months
36 months
R0-resection rate
Time Frame: 30 days
Defined as dysplasia free vertical and lateral resection margins at histology
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Comprehensive Cancer Centre The Netherlands

Investigators

  • Principal Investigator: L.M.G. Moons, MD, PhD, UMC Utrecht
  • Principal Investigator: A.D. Koch, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

January 8, 2016

First Submitted That Met QC Criteria

January 13, 2016

First Posted (Estimate)

January 15, 2016

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-610/D
  • TDM-H1/8051 (Other Grant/Funding Number: Dutch Cancer Society (DCS))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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