Cold Snare Polypectomy for non-pedunculated colonic polyps sized 10-19mm: A prospective observational study.
Cold Snare Polypectomy for non-pedunculated colonic polyps sized 10-19mm: A prospective observational study (CSP study).
Dr Dileep Mangira
350 participants
Apr 4, 2018
Observational
Conditions
Summary
Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres. It has not yet been adopted at most other non-academic endoscopy centres for polyps in this intermediate size range. It is now known that “cold snares” (that don’t use electrocautery) are effective for polyp resection. Cold snares use a thin, stiff, monofilament wire to cut out the polyp, without the need for electrocautery. This is a big advance, as it is the electrocautery that is the main cause of post-polypectomy complications such as bowel perforation, serositis, post-polypectomy syndrome, post-procedure pain and post-polypectomy bleeding. Therefore, polypectomy using cold snare has the potential to significantly reduce the risk of complications following colonoscopy. While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate-sized polyps is still limited. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for intermediate-sized polyps as well. However, to establish robust evidence, a well-designed, prospective, multicentre, observational study is required. The primary aim of this prospective observational multicentre study is to measure the incomplete resection rate of intermediate-sized sessile polyps as determined by the histological examination of polypectomy site biopsies. The major secondary aims include to measure residual polyp rate during first surveillance colonoscopy, measurement of immediate and delayed complications. All patients undergoing elective colonoscopy at all participating academic centres will be screened to assess their eligibility into the study based on exclusion and inclusion criteria. During the colonoscopy procedure if a medium sized polyp (10-19 mm) is detected and excised using cold snare polypectomy technique will become the part of the study. Study data Study data from multiple sites will be entered into an encrypted, password protected web-based database. The study is a prospective audit of all new cases of CSP for one year with an additional follow up to review endoscopic findings during the first routine surveillance colonoscopy. At least fifteen leading endoscopy centres around Australia are expected to contribute to the study. 350 polypectomy cases are expected to be recruited during the study during the first year, another two to three years of follow up is required to obtain results of the surveillance colonoscopies.
Eligibility
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Interventions
Removal of polyps via colonoscopy is effective at reducing the incidence of colorectal cancer. Cold snare polypectomy (CSP) is a relatively recent development but has rapidly gained international acceptance as an effective and safe polypectomy technique. In this technique, a dedicated snare made up of thin, monofilament wire is used to resect polyps without application of the heat(hence called cold snare polypectomy technique). It is now the standard of care internationally for resection of small polyps (i.e. sized <10mm), and has become the standard of care for resection of intermediate-sized polyps (sized 10-19mm) at leading academic endoscopy centres all around Australia and New Zealand. While the evidence for the efficacy of cold snare polypectomy for resection of small polyps is established, rigorous data for intermediate sized polyps is still limited. Effectively, this technique has become the standard of care at leading centres for polyps in this size range due to the overwhelming safety benefits, however, there are no prospective nor multicentre studies proving that this method is effective, in terms of completeness of resection of polyps. In our own practices, and in the setting of small, published retrospective studies, we have observed cold snare polypectomy to be very effective for polyps in this intermediate size range as well. However, to convince endoscopists that the safety benefits of cold snare polypectomy are also associated with highly effective complete resection of polyps, a well-designed, prospective, multicentre, observational study is required. All follow ups of the patients are part of the standard of care. During the first clinic follow up which is anywhere from 4 weeks to 12 weeks, information related to any delayed complications that have occurred will be documented. Similarly, first surveillance colonoscopy is also part of the standard of care which can be anywhere from 4 months to three years. Follow up colonoscopy information is collected after patients' first surveillance colonoscopy. In broader sense maximal possible duration of follow up for any suitable patient is three years from the time of the date of their index colonoscopy. However follow up is very focused at two specific points. First one during initial clinic review post procedure second post first surveillance colonoscopy.
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ACTRN12618000742279