Background The endoscopic submucosal dissection (ESD) is a technically demanding and time-consuming procedure, with an increased risk of adverse events compared to standard endoscopic resection techniques. The main difficulties are related to the instability of the operating field and to the loss of traction. We aimed to evaluate in a pilot trial a new endoscopic platform [tissue retractor system (TRS); ORISE, Boston scientific Co., Marlborough, MA, USA], designed to stabilize the intraluminal space, and to provide tissue retraction and counter traction. Method We prospectively enrolled all consecutive patients who underwent an ESD for sigmoid/rectal lesions. The primary outcome was the rate of technical feasibility. Further technical aspects such as en-bloc and R0 resection rate, number of graspers used, circumferential incision time, TRS assemblage time, submucosal dissection time, and submucosal dissection speed were provided. Clinical outcomes (recurrence rate and adverse events) were recorded as well. Results In all, 10 patients (M/F 4/6, age: 70.4 ± 11.0 years old) were enrolled. Eight out of 10 lesions were located in the rectum. Average lesion size was 31.2 ± 2.7 mm, and mean lesion area was 1628.88 ± 205.3 mm2. The two sigmoid lesions were removed through standard ESD, because the platform assemblage failed after several attempts. All rectal lesions were removed in an en-bloc fashion. R0 resection was achieved in 7/8 (87.5%) patients in an average procedure time of 60.5 ± 23.3 min. None of the patients developed neither intraprocedural nor postprocedural adverse events. Conclusion TRS-assisted ESD is a feasible option when used in the rectum, with promising result in terms of efficacy and safety outcomes. Nevertheless, our pilot study underlines few technical limitations of the present platform that need to be overcome before the system could be widely and routinely used.

中文翻译：

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结直肠内镜粘膜下剥离术新型内镜平台的初步研究。

背景 内镜粘膜下剥离术（ESD）是一项技术要求高且耗时的手术，与标准内镜切除技术相比，不良事件的风险增加。主要困难与操作场地的不稳定和牵引力的损失有关。我们的目的是在试点试验中评估一种新的内窥镜平台[组织牵开系统（TRS）；ORISE，波士顿科学公司，马尔伯勒，马萨诸塞州，美国]，旨在稳定管腔内空间，并提供组织回缩和反牵引。方法 我们前瞻性地招募了所有因乙状结肠/直肠病变接受 ESD 的连续患者。主要结果是技术可行性率。其他技术方面，例如整块和 R0 切除率、使用的抓握器数量、圆周切口时间、提供了 TRS 组装时间、粘膜下剥离时间和粘膜下剥离速度。还记录了临床结果（复发率和不良事件）。结果 共有 10 名患者（男/女 4/6，年龄：70.4 ± 11.0 岁）入组。十分之八的病变位于直肠。平均病变大小为 31.2 ± 2.7 mm，平均病变面积为 1628.88 ± 205.3 mm2。通过标准 ESD 切除了两个乙状结肠病变，因为平台组合在多次尝试后失败。所有直肠病变均以整块方式切除。7/8 (87.5%) 患者实现 R0 切除，平均手术时间为 60.5 ± 23.3 分钟。没有患者出现术中或术后不良事件。结论 TRS 辅助 ESD 在直肠中使用时是一种可行的选择，在功效和安全性方面取得了有希望的结果。尽管如此，我们的试点研究强调了当前平台的一些技术限制，在系统广泛和常规使用之前需要克服这些限制。