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

Primary Purpose

Colonic Polyps

Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Endoscopic Submucosal Dissection
Endoscopic Mucosal Resection
Sponsored by
Professor Michael Bourke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Polyps

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Westmead Endoscopy Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Endoscopic Mucosal Resection

Endoscopic Submucosal Dissection

Arm Description

Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.

Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 17, 2014
Last Updated
June 28, 2023
Sponsor
Professor Michael Bourke
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1. Study Identification

Unique Protocol Identification Number
NCT02198729
Brief Title
Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection
Acronym
RESDEMR
Official Title
Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2023 (Actual)
Study Completion Date
May 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Polyps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Mucosal Resection
Arm Type
Active Comparator
Arm Description
Participants randomised to this arm will receive standard of care Endoscopic Mucosal Resection for removal of their lesions.
Arm Title
Endoscopic Submucosal Dissection
Arm Type
Experimental
Arm Description
Participants randomised to this arm will receive Endoscopic Mucosal Dissection to remove their lesion.
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Submucosal Dissection
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Mucosal Resection
Primary Outcome Measure Information:
Title
Recurrence
Description
Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations
Time Frame
18 months
Secondary Outcome Measure Information:
Title
One piece resection rate
Description
Rate of en bloc resection
Time Frame
14 days
Title
Technical success of EMR
Description
Rate of initial technical success
Time Frame
14 days
Title
Recurrence
Description
Recurrence tissue observed at follow up colonoscopies over a 3 year period
Time Frame
up to 3 years
Title
complication rates
Description
Safety outcomes measured in the form of follow up phone calls.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael J Bourke, MBBS
Organizational Affiliation
Western Sydney Local Health District
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Endoscopy Unit
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia

12. IPD Sharing Statement

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Comparison Rectal Endoscopic Submucosal Dissection to Endoscopic Mucosal Resection

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