Clinical Trial: Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Cold Snare Polypectomy Versus Endoscopic Mucosal Resection for Colonic Sessile Serrated Polyps - A Randomised Controlled Trial

Brief Summary: Comparing the efficacy of cold snare polypectomy with endoscopic mucosal resection

Detailed Summary:

Colorectal cancer (CRC) is the third most common cancer and it remains the second most commonly diagnosed malignancy in Australia. Colonoscopic polypectomy reduces the incidence and mortality from CRC by disrupting the adenoma-carcinoma sequence. Screening for CRC has proven to be effective in reducing mortality and morbidity from CRC and has become common practice. Interval cancers (development of a CRC within 6 to 60 months of a colonoscopy) occur in 6% of patients and estimations showed that up to 27% of these are due to incomplete adenoma resection.

The serrated neoplasia pathway accounts for 20- 30% of sporadic cancers. Serrated precursor lesions are thought to be a major contributor to the relative failure of colonoscopy in the prevention of proximal colorectal cancer (CRC) and to the 5- 7% of CRCs which occur in the period after complete colonoscopy and prior to surveillance, termed 'interval' cancer.

In addition to being difficult to detect, sessile serrated polyps (SSPs) are more likely to be incompletely resected than conventional adenomas. The CARE study demonstrated that 31% of SSPs had remnant tissue in the resection defect compared with 7.2% of conventional adenomas, and in lesions greater than 10 mm in size, residual tissue remained in 47.5%. SSPs may have indistinct margins, and smaller lesions may prove difficult to entrap with the snare because of their flat nature. SSPs also may contain dysplastic foci within the lesion, with an endoscopic appearance indistinguishable from conventional adenomas, and the surrounding serrated component may be overlooked and incompletely resected if this is not recognized.

The technique of colonoscopic polypectomy is continually evolving, leading to better outcomes with regard to polyp detection rate, complete resection rate
Sponsor: Western Sydney Local Health District

Current Primary Outcome: Number of participants with residual or recurrent adenoma as assessed at surveillance endoscopy [ Time Frame: 4-6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of participants with bleeding after the EMR procedure has finished as assessed by telephone interview at 2 weeks [ Time Frame: 2 weeks ]
  • Number of participants with residual or recurrent adenoma as assessed at admission or telephone interview at 2 weeks [ Time Frame: 2 weeks ]
  • Number of participants with pain after EMR as assessed by VAS score and telephone interview at 2 weeks [ Time Frame: 2 weeks ]
    Pain after EMR


Original Secondary Outcome: Same as current

Information By: Western Sydney Local Health District

Dates:
Date Received: August 13, 2016
Date Started: August 2016
Date Completion: August 2019
Last Updated: November 15, 2016
Last Verified: November 2016