Clinical Trial: EMR Recurrence Assessment

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Prospective Study Stratifying Patients to Follow up Intervals Based on Risk of Recurrence Post Wide Field Colonic EMR

Brief Summary: To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case.

Detailed Summary:

Colonoscopy and polypectomy reduces the anticipated incidence of colorectal malignancy in patients with significant adenomatous polyps by approximately 80% in long term follow up. Most endoscopists routinely perform removal of small polyps. However, removal of flat colonic neoplasia 20mm in size or larger is more complex and requires specific endoscopic techniques, one such technique being termed wide field endoscopic mucosal resection (WF-EMR). Traditionally these lesions were treated surgically at significant expense to the healthcare system. Endoscopic treatment of large colonic polyps reduces health care costs by approximately $11,000 per patient treated, saves bed days and avoids surgery in more than 90% of patients.

EMR describes the endoscopic technique of treating colorectal adenomatous polyps with submucosal lifting and careful piecemeal snare resection. This procedure has been shown to be safe and effective at resecting lesions limited to the mucosa. Clearly the importance of predicting lesions that are unlikely to have invaded the deeper layers is of the utmost importance here, and significant improvements in our ability to assess this have been made in large volume centres such as Westmead

An important longer-term complication of EMR of large flat colonic neoplasia is the phenomenon of residual polyp tissue or polyp recurrence, which will be the focus of the proposed research study. Recurrence is detected by surveillance colonoscopies (SC), which are performed at defined intervals after the index procedure. Our current standard for safe surveillance interval at Westmead after >= 20mm EMR is 5 months (SC1). In the largest study to date, the Australian Colonic EMR (ACE) study, recurrence at SC1 stands at 16.5% for all patients.

We have recently come to the end
Sponsor: Western Sydney Local Health District

Current Primary Outcome: Adenoma recurrence [ Time Frame: 18 months ]

Recurrence of adenoma at 18 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Need for surgery [ Time Frame: 18 months ]
    need for surgery due to adenoma recurrence or complication
  • Bleeding after EMR [ Time Frame: 2 weeks ]
  • Pain after EMR [ Time Frame: 2 weeks ]
  • Delayed perforation after EMR [ Time Frame: 2 weeks ]


Original Secondary Outcome: Same as current

Information By: Western Sydney Local Health District

Dates:
Date Received: November 3, 2016
Date Started: January 2017
Date Completion: August 2020
Last Updated: November 4, 2016
Last Verified: November 2016