Endoscopy Division, Chiba Cancer Center, 666-2 Nitonacho, Chuo-ku, Chiba, Japan.
Sci Rep. 2022 Mar 17;12(1):4619. doi: 10.1038/s41598-022-08348-0.
Needle-type devices, such as the DualKnife (Olympus, Tokyo, Japan), are widely used for traction-assisted esophageal endoscopic submucosal dissection (ESD) but require a prolonged operation time. An improved model of the ITknife (Olympus), the ITknife nano, may allow faster and easier ESD than the DualKnife. We conducted a randomized study to compare the performances of the DualKnife and the ITknife nano for traction-assisted esophageal ESD. Patients with early esophageal squamous cell carcinoma were eligible for this study. The primary outcome was the total procedure time. The secondary outcomes were submucosal dissection time, en bloc, and complete resection rates, perforation rate, and adverse events. Results Fifty patients were equally divided into two groups: the DualKnife group (D-group) and the ITknife nano group (I-group), and all underwent the assigned treatment. The I-group had significantly shorter total procedure time (36.8 vs. 60.7 min; P < 0.01) and submucosal dissection time (17.2 vs. 35.8 min; P < 0.01) than the D-group. The en bloc and complete resection rates were sufficiently high in both groups (100% and 100% in the D-group and 100% and 96% in the I-group, respectively). Significantly fewer hemostatic procedures due to intraoperative bleeding were performed in the I-group than in the D-group (0.2 vs. 1.4; P < 0.01). Delayed bleeding, perforation, or esophageal stricture did not occur in either group. The ITknife nano exhibited lower procedure time for traction-assisted esophageal ESD than the DualKnife, without increasing adverse events.
针状器械，如 DualKnife（奥林巴斯，东京，日本），广泛用于牵引辅助食管内镜黏膜下剥离术（ESD），但需要较长的操作时间。ITknife（奥林巴斯）的改良模型 ITknife nano 可能比 DualKnife 允许更快更容易的 ESD。我们进行了一项随机研究，比较 DualKnife 和 ITknife nano 在牵引辅助食管 ESD 中的性能。患有早期食管鳞状细胞癌的患者符合本研究条件。主要结局是总手术时间。次要结局是黏膜下剥离时间、整块和完全切除率、穿孔率和不良事件。结果 50 名患者被平均分为两组：DualKnife 组（D 组）和 ITknife nano 组（I 组），并接受了指定的治疗。I 组的总手术时间（36.8 分钟对 60.7 分钟；P < 0.01）和黏膜下剥离时间（17.2 分钟对 35.8 分钟；P < 0.01）明显短于 D 组。两组的整块和完全切除率均很高（D 组为 100%和 100%，I 组为 100%和 96%）。I 组术中因出血导致的止血操作明显少于 D 组（0.2 次对 1.4 次；P < 0.01）。两组均未发生迟发性出血、穿孔或食管狭窄。ITknife nano 用于牵引辅助食管 ESD 的手术时间比 DualKnife 短，而不良事件发生率没有增加。
