RecruitingACTRN12618000742279

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).


Sponsor

Dr Dileep Mangira

Enrollment

350 participants

Start Date

Apr 4, 2018

Study Type

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

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

During a colonoscopy, any polyps found in the bowel are usually removed at the same time. For a long time, the standard technique for medium-sized polyps (10–19mm) involved using an electric current to cut them out — a method called hot snare polypectomy. A newer approach called cold snare polypectomy (which cuts the polyp with a fine wire without using electricity) has become the accepted standard for small polyps under 10mm, but its use for medium-sized polyps is still being studied. This large observational study across multiple Australian endoscopy centres is tracking outcomes for patients who have medium-sized polyps removed using the cold snare technique. By looking at how completely the polyps are removed, whether they come back at the first surveillance colonoscopy, and how often complications occur, the study aims to build robust evidence for or against adopting this gentler technique for medium-sized polyps. You may be eligible if you are 18 or older and have a sessile (flat or non-stalked) polyp between 10 and 19mm found during a colonoscopy at a participating centre. Polyps that look potentially cancerous, are on a stalk, or are associated with active inflammatory bowel disease would be handled differently. If you're having a colonoscopy at a participating centre, your doctor may ask if you'd like your polyp removal to be included in this study.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

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 acc

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.


Locations(16)

Footscray Hospital - Footscray

NSW,QLD,SA,WA,VIC, Australia

The Alfred - Prahran

NSW,QLD,SA,WA,VIC, Australia

Royal Melbourne Hospital - City campus - Parkville

NSW,QLD,SA,WA,VIC, Australia

Barwon Health - Geelong Hospital campus - Geelong

NSW,QLD,SA,WA,VIC, Australia

St John of God Hospita, Geelong - Geelong

NSW,QLD,SA,WA,VIC, Australia

Epworth Richmond - Richmond

NSW,QLD,SA,WA,VIC, Australia

Flinders Medical Centre - Bedford Park

NSW,QLD,SA,WA,VIC, Australia

The Royal Adelaide Hospital - Adelaide

NSW,QLD,SA,WA,VIC, Australia

Lyell McEwin Hospital - Elizabeth Vale

NSW,QLD,SA,WA,VIC, Australia

The Wesley Hospital - Auchenflower

NSW,QLD,SA,WA,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,SA,WA,VIC, Australia

Peel Health Campus - Mandurah

NSW,QLD,SA,WA,VIC, Australia

Princess Alexandra Hospital - Woolloongabba

NSW,QLD,SA,WA,VIC, Australia

Greenslopes Private Hospital - Greenslopes

NSW,QLD,SA,WA,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,SA,WA,VIC, Australia

Ballarat Health Services (Base Hospital) - Ballarat Central

NSW,QLD,SA,WA,VIC, Australia

View Full Details on ANZCTR

For the most up-to-date information, visit the official listing.

Visit

ACTRN12618000742279