A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial

Abstract

Background and aims: SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions.

Methods: In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant.

Results: Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P < .001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P < .001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P = .1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P = .04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P = .052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P = .1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment.

Conclusions: In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.).