Abstract
BACKGROUND: Complications of endoscopic mucosal resection (EMR) of large colorectal polyps remain a concern. OBJECTIVE: We aimed to compare safety and efficacy of cold EMR (without electrocautery) to hot EMR (with electrocautery) of large colorectal polyps. DESIGN: In this multicentre randomised trial, patients with any large (≥20 mm) non-pedunculated colon polyp were assigned to cold or hot EMR (primary intervention), and to submucosal injection with a viscous or non-viscous solution (secondary intervention) following a 2×2 design. The primary outcome was the rate of severe adverse events (SAEs). The secondary outcome was polyp recurrence. In this study, we report results of the primary intervention. RESULTS: 660 patients were randomised and analysed. An SAE was observed in 2.1% of patients in the cold EMR group and in 4.3% in the hot EMR group (p=0.10) (per protocol analysis 1.4 vs 5.0%, p=0.017) with fewer perforations following cold EMR (0%) compared with hot EMR (1.6%, p=0.028). Postprocedure bleeding did not differ (1.5% vs 2.2%, p=0.57). The effect of cold resection was independent of the type of submucosal injection solution, polyp size or antithrombotic medications. Recurrence was detected in 27.6% and 13.6% in the cold and hot EMR groups, respectively (p<0.001). Recurrence was not significantly different for 20-29 mm polyps (18.6% vs 13.4%, p=0.24) and for sessile serrated polyps (14.1% vs 8.5%, p=0.33). CONCLUSION: Universal application of cold EMR did not significantly lower SAEs (unless cold EMR could be completed) and doubled the recurrence rate compared with hot EMR. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov, number: NCT03865537.