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Completed

NCT Number: NCT02198729

Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection

The investigators have recently become proficient in a new, and we believe more effective technique for polyp removal. Known as Endoscopic Submucosal Dissection (ESD). ESD involves removing the polyp in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. There have also been recent studies overseas that have shown this new technique to be quite effective. In this study, half of the patients will receive the newly developed technique of polyp removal (ESD), while the other half will receive conventional Endoscopic Mucosal Resection (EMR) treatment. This study will allow us to show which technique results in lower recurrence rates and is more effective.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Endoscopy Unit

Westmead, New South Wales, 2145, Australia

About this study

EMR is a very effective procedure for lesions smaller than 20 mm. With this size the polyp can be removed en bloc. En bloc resection is preferred as it minimises the likelihood of residual adenoma and enhances histological assessment. It is also curative in superficially invasive submucosal disease. It eliminates the need for surgery in these patients. With lesions larger than 20 mm, the lesion is removed piece meal, often in more than 5 pieces. Care is taken to ensure that no adenoma is left behind at the point of overlap between snare resections. However, for every additional snare resection, there is the possibility that a small amount of adenoma will be left behind at this overlap point. Overall, the literature suggests that there is approximately a 15% residual adenoma rate at repeat colonoscopy in 3 months, which requires further treatment. With en bloc resection residual adenoma rate at repeat colonoscopy in is close to 0%. This has to be balanced against the relative inexperience with performing ESD, longer procedure time and higher complication rates. A randomized trial near completion is comparing endoscopic snare resection with transanal surgical resection for rectal polyps (24). Should this trial show that en bloc resection is superior in achieving complete resection without recurrence at similar complication rates, the endoscopic treatment strategy of large colorectal adenomas should be reconsidered. Since en bloc resection is technically more challenging, this should have consequences for credentialing, referral patterns and performance of removal of large colorectal polyps in reference centers only. Thus, before en bloc resection is promoted as superior, and training has to be intensified to comply with standards of safe oncologic resection of these lesions, the efficacy and safety have to be proven in a comparative randomized trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Can give informed consent to trial participation
  • Lesion size 20 mm to 50 mm
  • Laterally spreading or sessile polyp morphology

Exclusion criteria

  • Previous resection or attempted resection of target adenoma lesion
  • Endoscopic appearance of invasive malignancy
  • Age less than 18 years
  • Pregnancy
  • Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)
  • Use of anticoagulant or antiplatelet agents other than aspirin less than 5 days prior to procedure
  • American Society of Anesthesiology (ASA) Grade IV-V

Treatment and study plan

Endoscopic submucosal dissection

Procedure

Endoscopic mucosal resection

Procedure

Primary outcomes

  1. Recurrence

    Time frame: 18 months

    Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations

Secondary outcomes

  1. One piece resection rate

    Time frame: 14 days

    Rate of en bloc resection

  2. Technical success of EMR

    Time frame: 14 days

    Rate of initial technical success

  3. Recurrence

    Time frame: up to 3 years

    Recurrence tissue observed at follow up colonoscopies over a 3 year period

  4. complication rates

    Time frame: 14 days

    Safety outcomes measured in the form of follow up phone calls.

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study title

Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial

Acronym: RESDEMR

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Jul 24, 2014
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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