Efficacy and safety of SIC-8000 (Eleview®) for submucosal injection for endoscopic mucosal resection and endoscopic submucosal dissection in an in vivo porcine model.

BACKGROUND

Submucosal injection is generally required for both endoscopic-mucosal resection (EMR) and submucosal dissection (ESD). SIC-8000 (Eleview™) is a new FDA 510(k) cleared and CE marked liquid composition for submucosal injection, containing a biocompatible polymer as a cushioning agent.

AIMS

The aim of this randomized study was to compare Eleview with saline solution when performing upper- and lower-GI EMR/ESD in a porcine model.

METHODS

EMR/ESD procedures were performed in a total of 10 white domestic pigs comparing Eleview vs. NaCl 0.9% containing methylene blue at 0.001% (control solution) as submucosal solution to be injected. Animals were randomized between EMR (22 procedures) and ESD (22 procedures) and between upper- (8 animals) and lower-(2 animals) GI procedures. All procedures were performed aiming for a resection size of 1 cm × 1 cm for EMR and 2 cm × 2 cm for ESD. Volume of injected fluid, number of injections, time of resection, technical success, en-bloc resection, and adverse events were collected. Endoscopic surveillance was conducted each week for 4 weeks after the EMR/ESD, including biopsies on the margins of resection sites at week-1 of follow-up. After four weeks, pigs were sacrificed and necropsy performed.

RESULTS

Overall, 22 EMR and 22 ESD were performed in 10 live pigs. The average total volume needed for EMR and ESD was statistically significantly lower with Eleview as compared with control solution for both of the techniques (EMR: 5.6 ± 3.4 ml vs. 11.5 ± 6.7 ml; p = 0.02; ESD: 19.0 ± 10.0 ml vs. 36.3 ± 16.9 ml; p = 0.02). The rate of adverse events was statistically significantly lower in the Eleview than in the control group (2/26, 7.7% vs. 6/18, 33.3%; p = 0.03), but most of them were minor. No difference between Eleview and control solution was found in the rate of technical success (EMR: 11/13, 84.6% vs. 7/9, 77.8%; p = 0.7; ESD: 13/13, 100% vs. 9/9, 100%; p = 1), en-bloc resection (EMR: 6/13, 46.2% vs. NaCl: 5/9, 55.6%; p = 0.06; ESD: 12/13, 92.3% vs. 8/9, 88.9%; p = 0.8), and time of resection (EMR: 9.1 ± 7.75 min vs. 9.4 ± 9.6 min; p = NS; ESD: 38.4 ± 17.2 min vs. 40.2 ± 19.1 min; p = NS). At endoscopic follow up and necropsy, no difference in the process of healing of post-endoscopic ulcer and in the histological inflammation at the site of resection was shown between the two groups.

CONCLUSIONS

The new submucosal injection composition Eleview appeared to be an effective alternative to saline solution for submucosal injection for EMR/ESD, resulting in a substantial reduction of the volume administered to achieve an adequate lifting. No signs of adverse local or distant tissue reaction to Eleview were found at long-term follow up.