Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection (RESDEMR)

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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Polyps
• Intervention / Treatment: Procedure: Endoscopic Mucosal Resection; Procedure: Endoscopic Submucosal Dissection

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Westmead, New South Wales, Australia, 2145
      • Westmead Endoscopy Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endoscopic Mucosal Resection; Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.	Procedure: Endoscopic Mucosal Resection
Experimental: Endoscopic Submucosal Dissection; Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.	Procedure: Endoscopic Submucosal Dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence	Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
One piece resection rate	Rate of en bloc resection	14 days
Technical success of EMR	Rate of initial technical success	14 days
Recurrence	Recurrence tissue observed at follow up colonoscopies over a 3 year period	up to 3 years
complication rates	Safety outcomes measured in the form of follow up phone calls.	14 days

Collaborators and Investigators

• Sponsor: Professor Michael Bourke
• Investigators: Principal Investigator: Michael J Bourke, MBBS, Western Sydney Local Health District

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 17, 2014
• First Submitted That Met QC Criteria: July 22, 2014
• First Posted (Estimated): July 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Polyps; Polyps; Colonic Polyps
• Other Study ID Numbers: HREC2013/10/4.2(3830)