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

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ClinicalTrials.gov Identifier: NCT02198729
Recruitment Status : Recruiting
First Posted : July 24, 2014
Last Update Posted : November 14, 2017
Sponsor:
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.

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 2018
Estimated Study Completion Date : May 2019

Resource links provided by the National Library of Medicine


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.



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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT02198729


Contacts
Contact: Rebecca Sonson 98455555 ext 59779 Rebecca.Sonson@health.nsw.gov.au

Locations
Australia, New South Wales
Westmead Endoscopy Unit Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Rebecca Sonson, BN    98455555 ext 59779    Rebecca.Sonson@health.nsw.gov.au   
Contact: Michael J Bourke, MBBS    98455555 ext 56700    bec2153@gmail.com   
Principal Investigator: Michael J Bourke, MBBS         
Sub-Investigator: Farzan F Bahin, MBBS         
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael J Bourke, MBBS Western Sydney Local Health District

Responsible Party: Professor Michael Bourke, Director of Gastrointestinal Endoscopy, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT02198729     History of Changes
Other Study ID Numbers: HREC2013/10/4.2(3830)
First Posted: July 24, 2014    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps