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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02198729
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : July 5, 2019
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District

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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Procedure: Endoscopic Submucosal Dissection Procedure: Endoscopic Mucosal Resection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endoscopic Submucosal Dissection Versus Endoscopic Mucosal Resection for Sessile Polyps and Laterally Spreading Lesions of the Rectum - a Prospective Randomised Trial
Study Start Date : July 2014
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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

Primary Outcome Measures :
  1. Recurrence [ Time Frame: 18 months ]
    Recurrence rate - free of adenoma endoscopically and histologically on 2 subsequent examinations

Secondary Outcome Measures :
  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. Safety [ Time Frame: 14 days ]
    Safety outcomes measured in the form of follow up phone calls.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02198729

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Contact: Rebecca Sonson 98455555 ext 59779

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Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779   
Contact: Michael J Bourke, MBBS    98455555 ext 56700   
Principal Investigator: Michael J Bourke, MBBS         
Sub-Investigator: Farzan F Bahin, MBBS         
Sponsors and Collaborators
Professor Michael Bourke
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Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District
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Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District Identifier: NCT02198729    
Other Study ID Numbers: HREC2013/10/4.2(3830)
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps