SIC-8000 versus hetastarch as a submucosal injection fluid for endoscopic mucosal resection: a randomized controlled trial

Background and Aims Viscous solutions provide a superior submucosal cushion for endoscopic mucosal resection (EMR). SIC-8000 (Eleview, Aries Pharmaceuticals, La Jolla, Calif) is a commercially available FDA approved solution but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 to hetastarch as submucosal injection agents for colorectal EMR. Methods This was a single-center double-blinded randomized controlled trial performed at a tertiary referral center. Patients were referred to our center with flat or sessile lesions measuring ≥15 mm in size. The primary outcome measures were the Sydney Resection Quotient (SRQ) and the rate of en bloc resections. Secondary outcomes were total volume needed for a sufficient lift, number of resected pieces, and adverse events. Results There were 158 patients with 159 adenomas (84 SIC-8000 and 75 hetastarch) and 57 serrated lesions (30 SIC-8000 and 27 hetastarch). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, p=0.001). There was no difference in the proportion of lesions with en bloc resections. The total volume of injectate was significantly lower with SIC-8000 (14.8 mL vs 20.6 mL, p=0.038) Conclusions SIC-8000 is superior to hetastarch for use during EMR in terms of SRQ and total volume needed, although the absolute differences were small

A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial

Background and Aims Endocuff and Endocuff Vision are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE is a knock-off device that appears similar to the Endocuff devices but has received minimal clinical testing. Methods We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. Results The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (2.83) versus 1.51 (2.29) with Endocuff Vision; p=0.535. The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (p=0.008). There was no difference between the arms in mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, p=0.042). Conclusions AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision of which device to use can be based on cost. Additional comparisons of AmplifEYE to Endocuff by other investigators are warranted

Impact of a ring fitted cap on insertion time and adenoma detection: a randomized controlled trial

Background and Aims: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring fitted cap (EndoRings, EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy. Methods: A single-center randomized controlled trial of 562 patients (284 randomized to EndoRings and 278 to standard colonoscopy) at 2 outpatient endoscopy units in the Indiana University Hospital system. Adenoma detection was the primary outcome measured as adenoma detection rate (ADR) and adenomas per colonoscopy (APC). We also compared sessile serrated polyp detection rate (SSPDR), insertion times, withdrawal times, and ease of passage through the sigmoid colon. Results: EndoRings was superior to standard colonoscopy in terms of APC (1.46 vs 1.06, p=0.025) but there were no statistically significant differences in ADR or SSPDR. Mean withdrawal time (in patients with no polyps) was shorter and insertion time (all patients) was longer in the EndoRings arm by 1.8 minutes and 0.75 minutes, respectively. One provider had significantly higher detection with EndoRings and contributed substantially to the overall results. Conclusions: EndoRings can increase adenoma detection without significant increase in procedure time, but the effect varies between operators. EndoRings slows colonoscope insertion