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

Douglas Rex, Heather M. Broadley, Jonathan R. Garcia, Rachel E. Lahr, Margaret E. MacPhail, Connor D. McWhinney, Meghan P. Searight, Andrew W. Sullivan, Neal Mahajan, George J. Eckert, Krishna C. Vemulapalli

Research output: Contribution to journalArticle

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.)

Original languageEnglish (US)
JournalGastrointestinal endoscopy
DOIs
StateAccepted/In press - Jan 1 2019

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Hydroxyethyl Starch Derivatives
Randomized Controlled Trials
Injections
Tertiary Care Centers
Pharmaceutical Preparations
Adenoma
Outcome Assessment (Health Care)
Clinical Trials
Food

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Rex, D., Broadley, H. M., Garcia, J. R., Lahr, R. E., MacPhail, M. E., McWhinney, C. D., ... Vemulapalli, K. C. (Accepted/In press). SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial. Gastrointestinal endoscopy. https://doi.org/10.1016/j.gie.2019.06.040

SIC-8000 versus hetastarch as a submucosal injection fluid for EMR : a randomized controlled trial. / Rex, Douglas; Broadley, Heather M.; Garcia, Jonathan R.; Lahr, Rachel E.; MacPhail, Margaret E.; McWhinney, Connor D.; Searight, Meghan P.; Sullivan, Andrew W.; Mahajan, Neal; Eckert, George J.; Vemulapalli, Krishna C.

In: Gastrointestinal endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Rex, D, Broadley, HM, Garcia, JR, Lahr, RE, MacPhail, ME, McWhinney, CD, Searight, MP, Sullivan, AW, Mahajan, N, Eckert, GJ & Vemulapalli, KC 2019, 'SIC-8000 versus hetastarch as a submucosal injection fluid for EMR: a randomized controlled trial', Gastrointestinal endoscopy. https://doi.org/10.1016/j.gie.2019.06.040
Rex, Douglas ; Broadley, Heather M. ; Garcia, Jonathan R. ; Lahr, Rachel E. ; MacPhail, Margaret E. ; McWhinney, Connor D. ; Searight, Meghan P. ; Sullivan, Andrew W. ; Mahajan, Neal ; Eckert, George J. ; Vemulapalli, Krishna C. / SIC-8000 versus hetastarch as a submucosal injection fluid for EMR : a randomized controlled trial. In: Gastrointestinal endoscopy. 2019.
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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.

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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.)

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