Background and Aims

SIC-8000 (Eleview) is a new U.S. Food and Drug Administration (FDA)-approved solution for submucosal injection developed to provide a long-lasting cushion to facilitate endoscopic resection maneuvers. Our aim was to compare the efficacy and safety of SIC-8000 with those of saline solution, when performing EMR of large colorectal lesions.

Methods

In a randomized double-blind trial, patients undergoing EMR for colorectal non-pedunculated lesions ≥20 mm were randomized in a 1:1 ratio between SIC-8000 and saline solution as control solution in 5 tertiary centers. Endoscopists and patients were blinded to the type of submucosal solution used. Total volume to complete EMR and per lesion size and time of resection were primary endpoints; the Sydney Resection Quotient (SRQ), as well as other EMR outcomes, and the rate of adverse events were secondary endpoints. A 30-day telephone follow-up was performed. An alpha level <0.05 was considered as statistically significant.

Results

Of the 327 patients screened, 226 (mean age, 66 ± 10 years; males, 56%) were enrolled in the study and randomized between the 2 submucosal agents. Of these, 211 patients (mean size of the lesions 33 ± 13 mm; Paris class Is, 36%; proximal colon, 74%) were entered in the final analysis (SIC-8000, 102; saline solution, 109). EMR was complete in all cases. The total volume needed for EMR was significantly less in the SIC-8000 arm compared with saline group (16.1 ± 9.8 mL vs 31.6 ± 32.0 mL; P < .001). This corresponded to an average volume per lesion size of 0.5 ± 0.3 mL/mm and 0.9 ± 0.6 mL/mm with SIC-8000 and saline solution, respectively (P < .001). The mean time to completely resect the lesion tended to be lower with SIC-8000 than with saline solution (19.1 ± 16.8 minutes vs 29.7 ± 68.9 minutes; P = .1). The SRQ was significantly higher with SIC-8000 compared with saline solution (10.3 ± 8.1 vs 8.0 ± 5.7; P = .04) with a trend for a lower number of resected pieces (5.7 ± 6.0 vs 6.5 ± 5.04; P = .052) and a higher rate of en bloc resections (19/102, 18.6% vs 12/111, 11.0%; P = .1). The rate of adverse events was similar between the 2 arms (SIC-8000, 18.6%; saline solution, 17%), and none of the serious adverse events (SIC-8000, 8.8%; saline solution, 10.7%) were related to the study treatment.

Conclusions

In a double-blind, randomized clinical trial, a new FDA-approved agent for sub-mucosal injection appeared to be a more effective and equally safe submucosal agent for EMR injection than saline solution. (Clinical trial registration number: NCT02654418.)

中文翻译：

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用于大肠直肠癌内镜切除的新型粘膜下注射溶液：一项随机，双盲试验

背景和目标

SIC-8000（Eleview）是美国食品药品监督管理局（FDA）批准的一种新的粘膜下注射解决方案，其开发目的是提供长效缓冲垫，以利于内窥镜切除手术。我们的目的是比较进行大肠癌病灶EMR时SIC-8000与盐溶液的疗效和安全性。

方法

在一项随机双盲试验中，在5个三级中心，以SIC-8000与盐溶液（作为对照溶液）之间的1：1比例将接受EMR且≥20 mm的大肠未去蒂病灶的患者随机分组。内镜医师和患者对所使用的粘膜下溶液的类型视而不见。主要的研究终点是完成EMR的总体积，每个病变的大小和切除时间。悉尼切除商数（SRQ）以及其他EMR结果以及不良事件发生率是次要终点。进行了30天的电话随访。α水平<0.05被认为具有统计学意义。

结果

在筛查的327例患者中，有226例（平均年龄66±10岁；男性，56％）参加了研究，并随机分配到2种粘膜下药物之间。在这些患者中，有211名患者（病灶平均大小为33±13 mm；巴黎I级为36％；近端结肠为74％）进入了最终分析（SIC-8000，102；盐溶液，109）。在所有情况下，EMR均已完成。与盐水组相比，SIC-8000组中EMR所需的总体积明显减少（16.1±9.8 mL对31.6±32.0 mL；P  <.001）。这分别对应于SIC-8000和盐溶液的每个病变大小的平均体积分别为0.5±0.3 mL / mm和0.9±0.6 mL / mm（P <.001）。使用SIC-8000完全切除病变的平均时间往往比使用盐溶液的时间要短（19.1±16.8分钟vs 29.7±68.9分钟；P  = 0.1）。与盐溶液相比，SIC-8000的SRQ显着更高（10.3±8.1 vs 8.0±5.7；P  = .04），并且切除的碎片数量也有减少的趋势（5.7±6.0 vs 6.5±5.04；P  = .052） ）和整体切除率更高（19 / 102，18.6％，而12 / 111，11.0％；P  = .1）。两组之间的不良事件发生率相似（SIC-8000，18.6％；盐溶液，17％），没有严重的不良事件（SIC-8000，8.8％；盐溶液，10.7％）与研究治疗。

结论

在一项双盲，随机临床试验中，一种新的FDA批准的粘膜下注射剂比盐溶液更有效和同样安全的EMR注射粘膜下剂。（临床试验注册号：NCT02654418。）