Cold endoscopic resection of large colorectal polyps: A randomized trial
(Cold snare EMR trial)
This study enrolls adults who have large colorectal polyp and are having a colonoscopy. The purpose of this study is to compare two different methods of removing the polyp.
The two ways to remove a large polyp, and there are also different solutions that are used to lit the polyp. In this study, we will compare how patients feel and whether their polyp comes back after using different combinations of these methods. We will assign you to either remove the polyp by “hot snare” or “cold snare” with one of the two injection fluids. This assignment is random, which means by chance, like tossing a coin. We will call you 30 days after your procedure to see how you are doing.
(CSR#200203749530) This protocol describes an investigator initiated clinical trial, which addresses an important challenge in the prevention of colorectal cancer: how to safely and effectively remove large polyps.
Large polyps pose a significant cancer risk. They are traditionally removed by endoscopic mucosal resection (EMR) using electrocautery snares. This EMR technique (also called hot snare EMR) is associated with a risk of major adverse events, which may require hospitalization and/or additional interventions. Recent studies suggest that snare resection without electrocautery so-called cold snare resection may decrease the risk of complications. Furthermore, there is uncertainty about the optimal resection technique. One important aspect that may affect efficacy is the type of submucosal injection to lift the polyp before its removal.
This trial will randomize 650 patients with a 20mm large polyp in a 2 x 2 factorial design to one of two submucosal injections and to either undergo cold or hot snare EMR. For the primary comparison (cold vs. hot snare EMR) the primary outcome will be incidence of any severe complication. We will further examine the recurrence rate of neoplastic polyps at follow-up colonoscopy, and investigate factors that may be associated with procedural complications and polyp recurrence.
The trial is timely, as recent studies suggest that cold snare EMR may be safer than hot snare EMR and still allow effective polyp removal. It is designed as a comparative effectiveness study, which will provide data on safety and efficacy. The study will further provide data to better understand whether there is a preferred submucosal injection agent to improve efficacy of resection. The findings of the trial will therefore help to identify a safe resection practice and contribute to the development of resection standards for polypectomy.
Adults ages 18+
Presenting for a colonoscopy
Have a large colorectal polyp
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