OBJECTIVES: Settings for endoscopic submucosal dissection (ESD) of esophageal cancer have not been standardized, and no studies have directly compared ESD devices in humans. METHODS: We conducted a randomized study to compare the performances of two different endo-knives, the Flush knife and Mucosectom, for esophageal ESD in 48 lesions. All procedures were initiated by two endoscopists, who were assisted by senior endoscopists with verbal advice. In the Flush-knife group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection using a 1-mm Flush knife. In the Mucosectom group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection with a Mucosectom. The primary outcome variable was the procedure time required for submucosal dissection. The secondary outcome variables were total procedure time, self-completion rates, and adverse events. RESULTS:Total procedure time in the Mucosectom group was significantly shorter than in the Flush-knife group (57±21 vs. 83±27 min, respectively; P<0.001). The submucosal-dissection time in the Mucosectom group was significantly shorter than in the Flush-knife group (40±18 vs. 61±23 min, respectively; P<0.001). The self-completion rate in the Mucosectom group was slightly higher than in the Flush-knife group, but the difference was not significant (91.7% vs. 75%, respectively; P=0.25). One perforation and one postoperative bleeding occurred in the Flush-knife group, both of which were treated successfully by endoscopic treatment. CONCLUSIONS: The Mucosectom reduced the procedure and submucosal-dissection times of esophageal ESD, without increasing adverse events.
RCT Entities:
OBJECTIVES: Settings for endoscopic submucosal dissection (ESD) of esophageal cancer have not been standardized, and no studies have directly compared ESD devices in humans. METHODS: We conducted a randomized study to compare the performances of two different endo-knives, the Flush knife and Mucosectom, for esophageal ESD in 48 lesions. All procedures were initiated by two endoscopists, who were assisted by senior endoscopists with verbal advice. In the Flush-knife group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection using a 1-mm Flush knife. In the Mucosectom group, mucosal incision with a 2-mm Flush knife was followed by submucosal dissection with a Mucosectom. The primary outcome variable was the procedure time required for submucosal dissection. The secondary outcome variables were total procedure time, self-completion rates, and adverse events. RESULTS: Total procedure time in the Mucosectom group was significantly shorter than in the Flush-knife group (57±21 vs. 83±27 min, respectively; P<0.001). The submucosal-dissection time in the Mucosectom group was significantly shorter than in the Flush-knife group (40±18 vs. 61±23 min, respectively; P<0.001). The self-completion rate in the Mucosectom group was slightly higher than in the Flush-knife group, but the difference was not significant (91.7% vs. 75%, respectively; P=0.25). One perforation and one postoperative bleeding occurred in the Flush-knife group, both of which were treated successfully by endoscopic treatment. CONCLUSIONS: The Mucosectom reduced the procedure and submucosal-dissection times of esophageal ESD, without increasing adverse events.