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SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial.
Gastrointest Endosc 2019; 90(5):807-812GE

Abstract

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.).

Authors+Show Affiliations

Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana, USA.Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

31288028

Citation

Rex, Douglas K., et al. "SIC-8000 Versus Hetastarch as a Submucosal Injection Fluid for EMR: a Randomized Controlled Trial." Gastrointestinal Endoscopy, vol. 90, no. 5, 2019, pp. 807-812.
Rex DK, Broadley HM, Garcia JR, et al. SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. Gastrointest Endosc. 2019;90(5):807-812.
Rex, D. K., Broadley, H. M., Garcia, J. R., Lahr, R. E., MacPhail, M. E., McWhinney, C. D., ... Vemulapalli, K. C. (2019). SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. Gastrointestinal Endoscopy, 90(5), pp. 807-812. doi:10.1016/j.gie.2019.06.040.
Rex DK, et al. SIC-8000 Versus Hetastarch as a Submucosal Injection Fluid for EMR: a Randomized Controlled Trial. Gastrointest Endosc. 2019;90(5):807-812. PubMed PMID: 31288028.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. AU - Rex,Douglas K, AU - Broadley,Heather M, AU - Garcia,Jonathan R, AU - Lahr,Rachel E, AU - MacPhail,Margaret E, AU - McWhinney,Connor D, AU - Searight,Meghan P, AU - Sullivan,Andrew W, AU - Mahajan,Neal, AU - Eckert,George J, AU - Vemulapalli,Krishna C, Y1 - 2019/07/06/ PY - 2019/05/14/received PY - 2019/06/27/accepted PY - 2019/7/10/pubmed PY - 2019/7/10/medline PY - 2019/7/10/entrez SP - 807 EP - 812 JF - Gastrointestinal endoscopy JO - Gastrointest. Endosc. VL - 90 IS - 5 N2 - 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.). SN - 1097-6779 UR - https://www.unboundmedicine.com/medline/citation/31288028/SIC-8000_versus_hetastarch_as_a_submucosal_injection_fluid_for_EMR:_a_randomized_controlled_trial L2 - https://linkinghub.elsevier.com/retrieve/pii/S0016-5107(19)32030-9 DB - PRIME DP - Unbound Medicine ER -