Belle Sebastian, von Boscamp Manuel, Sold Moritz, Mack Susanne, Pilz Lothar, Ebert Matthias, Kaehler Georg
a Department of Internal Medicine II , Medical Faculty Mannheim, University of Heidelberg , Mannheim , Germany.
b Department of Surgery, Medical Faculty Mannheim , University of Heidelberg , Mannheim , Germany.
Scand J Gastroenterol. 2017 Feb;52(2):222-227. doi: 10.1080/00365521.2016.1246606. Epub 2016 Oct 31.
Endoscopic mucosal resection (EMR) of colorectal adenomas leads to a reduced incidence of, and mortality from, colorectal carcinoma. Large adenomas are especially difficult to resect. Submucosal injection is a key part of EMR, as it allows for complete resection and decreased complications. We previously demonstrated in both animal models and a clinical trial that a focussed fluid beam applied to the mucosa creates selective fluid cushions in the submucosa selective tissue elevation by pressure (STEP). In this study, we examined the potential of this new technique compared to the standard inject and cut technique.
This was a monocentric prospective two armed randomised controlled clinical trial comparing the STEP technique to the standard needle injection. We included patients with Yamada I and II adenomas ≥12 mm.
One hundred fifty-five patients were treated in the trial. With the STEP technique there was a significantly higher rate of en-bloc resection, whereas piecemeal resection was more common in the standard arm. The odds ratio of piecemeal resection was 2.422 with a 95% confidence interval of 1.163-5.045 (p value .0195). There was no significant difference in resection time between the two techniques, while there was a significant difference in resections speed for the STEP technique. There was also no difference in complication rates.
This study demonstrated that the new STEP technique leads to a higher rate of en-bloc resections than the standard injection technique in endoscopic mucosa resection of colorectal adenomas. The STEP technique can play an important role in the future of EMR.
大肠腺瘤的内镜黏膜切除术（EMR）可降低结直肠癌的发病率和死亡率。大型腺瘤尤其难以切除。黏膜下注射是EMR的关键部分，因为它能实现完整切除并减少并发症。我们之前在动物模型和一项临床试验中均证明，聚焦于黏膜的液束可在黏膜下层形成选择性液垫，通过压力实现选择性组织抬升（STEP）。在本研究中，我们将这项新技术与标准的注射及切割技术相比较，检验了其潜力。
这是一项单中心前瞻性双臂随机对照临床试验，将STEP技术与标准针式注射进行比较。我们纳入了山田I型和II型、直径≥12毫米的腺瘤患者。
该试验共治疗了155例患者。采用STEP技术时，整块切除率显著更高，而在标准组中，分片切除更为常见。分片切除的优势比为2.422，95%置信区间为1.163 - 5.045（p值为 .0195）。两种技术的切除时间无显著差异，但STEP技术的切除速度有显著差异。并发症发生率也无差异。
本研究表明，在大肠腺瘤的内镜黏膜切除术中，新的STEP技术比标准注射技术能实现更高的整块切除率。STEP技术在未来的EMR中可发挥重要作用。
