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

NCT02657044 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 212

Last updated 2016-10-26

No results posted yet for this study

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.

Conditions

  • Colorectal Neoplasms

Interventions

PROCEDURE

EMR

PROCEDURE

ESD

Sponsors & Collaborators

  • Comprehensive Cancer Centre The Netherlands

    collaborator OTHER

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • L.M.G. Moons, MD, PhD · UMC Utrecht

  • A.D. Koch, MD, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-09-30
Completion
2020-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657044 on ClinicalTrials.gov