SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial

      Background and Aims

      Viscous solutions provide a superior submucosal cushion for EMR. SIC-8000 (Eleview; Aries Pharmaceuticals, La Jolla, Calif) is a commercially available U.S. Food and Drug Administration–approved solution, but hetastarch is also advocated. We performed a randomized trial comparing SIC-8000 with 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 (SIC-8000, 84; hetastarch, 75) and 57 serrated lesions (SIC-8000, 30; hetastarch, 27). SRQ was significantly better in the SIC-8000 group compared with hetastarch group (9.3 vs 8.1, P = .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 = .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. (Clinical trial registration number: NCT03350217.)

      Graphical abstract

      Abbreviation:

      SRQ (Sydney resection quotient)
      To read this article in full you will need to make a payment

      Purchase one-time access:

      Academic & Personal: 24 hour online accessCorporate R&D Professionals: 24 hour online access
      One-time access price info
      • For academic or personal research use, select 'Academic and Personal'
      • For corporate R&D use, select 'Corporate R&D Professionals'

      Subscribe:

      Subscribe to Gastrointestinal Endoscopy
      Already a print subscriber? Claim online access
      Already an online subscriber? Sign in
      Institutional Access: Sign in to ScienceDirect

      References

        • Yandrapu H.
        • Desai M.
        • Siddique S.
        • et al.
        Normal saline solution versus other viscous solutions for submucosal injection during endoscopic mucosal resection: a systematic review and meta-analysis.
        Gastrointest Endosc. 2017; 85: 693-699
        • Fujishiro M.
        • Yahagi N.
        • Kashimura K.
        • et al.
        Comparison of various submucosal injection solutions for maintaining mucosal elevation during endoscopic mucosal resection.
        Endoscopy. 2004; 36: 579-583
        • Moss A.
        • Bourke M.J.
        • Metz A.J.
        A randomized, double-blind trial of succinylated gelatin submucosal injection for endoscopic resection of large sessile polyps of the colon.
        Am J Gastroenterol. 2010; 105: 2375-2382
        • Fasoulas K.
        • Lazaraki G.
        • Chatzimavroudis G.
        • et al.
        Endoscopic mucosal resection of giant laterally spreading tumors with submucosal injection of hydroxyethyl starch: comparative study with normal saline solution.
        Surg Laparosc Endosc Percutan Tech. 2012; 22: 272-278
        • Repici A.
        • Wallace M.
        • Sharma P.
        • et al.
        A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial.
        Gastrointest Endosc. 2018; 88: 527-535
        • Hewett D.G.
        • Kaltenbach T.
        • Sano Y.
        • et al.
        Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging.
        Gastroenterology. 2012; 143: 599-607
        • Tutticci N.J.
        • Hewett D.G.
        Cold EMR of large sessile serrated polyps at colonoscopy (with video).
        Gastrointest Endosc. 2018; 87: 837-842