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.
Gastrointest Endosc. 2019 Nov;90(5):807-812. doi: 10.1016/j.gie.2019.06.040. Epub 2019 Jul 6.
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.
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.
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).
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.).
粘性溶液可为 EMR 提供更好的黏膜下缓冲。SIC-8000（Eleview；Aries Pharmaceuticals，加利福尼亚州拉霍亚）是一种市售的获得美国食品和药物管理局批准的溶液，但也提倡使用支链淀粉。我们进行了一项随机试验，比较 SIC-8000 与支链淀粉作为结直肠 EMR 的黏膜下注射剂。
这是一项在三级转诊中心进行的单中心、双盲、随机对照试验。患者因大小≥15mm 的扁平或息肉状病变而被转诊至我们中心。主要结局指标是悉尼切除商数（SRQ）和整块切除率。次要结局指标是充分提升所需的总体积、切除块数和不良事件。
共有 158 例患者（SIC-8000 组 84 例，支链淀粉组 75 例）和 57 例锯齿状病变（SIC-8000 组 30 例，支链淀粉组 27 例）。与支链淀粉组相比，SIC-8000 组的 SRQ 显著更好（9.3 比 8.1，P=0.001）。整块切除率无差异。SIC-8000 组的注射总量明显较低（14.8 毫升比 20.6 毫升，P=0.038）。
在 EMR 中，SIC-8000 在 SRQ 和所需总容积方面优于支链淀粉，尽管绝对差异较小。（临床试验注册号：NCT03350217.）。
