BACKGROUND AND AIMS: Colorectal endoscopic submucosal dissection (ESD) is a time-consuming procedure because of the technical difficulty. The newly developed saline-pocket ESD (SP-ESD) provides a clearer view and better traction of the submucosal layer compared with the standard ESD with gas insufflation (S-ESD). This study aimed to prospectively compare the efficacy and safety between S-ESD and SP-ESD in patients with superficial colorectal neoplasms (SCNs). METHODS:From April 2017 to November 2018, 95 patients with SCNs≥20 mm in diameter were prospectively and randomly enrolled. Four patients were excluded because of an incomplete ESD procedure. Patients were finally allocated to 2 groups, S-ESD with 45 patients and SP-ESD with 46 patients. The primary outcome was dissection speed. Secondary outcomes were ESD procedure time, en bloc and complete resection rates, perforation rate, and adverse effects. RESULTS:Median dissection speed was significantly faster in the SP-ESD than the S-ESD group (20.1 mm2/min [range, 17.3-28.1] vs 16.3 mm2/min [range, 11.4-19.8]; P < .001). Median procedure time was significantly shorter in the SP-ESD than the S-ESD group (29.5 minutes [range, 22.3-44] vs 41 minutes [range, 31-55]; P < .001). The en bloc and complete resection rates were 100% in both groups. No perforations occurred among patients. The volume of saline solution used in the SP-ESD group was significantly greater than that in the S-ESD group (200 mL [range, 120-250] vs 150 mL [range, 100-200]; P = .016). CONCLUSIONS: SP-ESD improved dissection speed and procedure time compared with S-ESD. SP-ESD may be an alternative method for resection of SCNs. (Clinical trial registration number: UMIN 000026317.).
RCT Entities:
BACKGROUND AND AIMS: Colorectal endoscopic submucosal dissection (ESD) is a time-consuming procedure because of the technical difficulty. The newly developed saline-pocket ESD (SP-ESD) provides a clearer view and better traction of the submucosal layer compared with the standard ESD with gas insufflation (S-ESD). This study aimed to prospectively compare the efficacy and safety between S-ESD and SP-ESD in patients with superficial colorectal neoplasms (SCNs). METHODS: From April 2017 to November 2018, 95 patients with SCNs ≥20 mm in diameter were prospectively and randomly enrolled. Four patients were excluded because of an incomplete ESD procedure. Patients were finally allocated to 2 groups, S-ESD with 45 patients and SP-ESD with 46 patients. The primary outcome was dissection speed. Secondary outcomes were ESD procedure time, en bloc and complete resection rates, perforation rate, and adverse effects. RESULTS: Median dissection speed was significantly faster in the SP-ESD than the S-ESD group (20.1 mm2/min [range, 17.3-28.1] vs 16.3 mm2/min [range, 11.4-19.8]; P < .001). Median procedure time was significantly shorter in the SP-ESD than the S-ESD group (29.5 minutes [range, 22.3-44] vs 41 minutes [range, 31-55]; P < .001). The en bloc and complete resection rates were 100% in both groups. No perforations occurred among patients. The volume of saline solution used in the SP-ESD group was significantly greater than that in the S-ESD group (200 mL [range, 120-250] vs 150 mL [range, 100-200]; P = .016). CONCLUSIONS:SP-ESD improved dissection speed and procedure time compared with S-ESD. SP-ESD may be an alternative method for resection of SCNs. (Clinical trial registration number: UMIN 000026317.).
Authors: Paolo Cecinato; Matteo Lucarini; Chiara Campanale; Francesco Azzolini; Fabio Bassi; Romano Sassatelli Journal: Endosc Int Open Date: 2022-09-14