Randomized study of two endo-knives for the traction-assisted endoscopic submucosal dissection of early esophageal squamous cell carcinoma

Abstract

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.