Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors
This prospective, randomized pilot study will compare traction-assisted endoscopic submucosal dissection (T-ESD) with conventional endoscopic submucosal dissection (C-ESD) for the treatment of rectal neuroendocrine tumors. Patients with rectal neuroendocrine tumors generally measuring 15 mm or less, without suspected muscularis propria invasion, lymph node metastasis, or distant metastasis, who are considered suitable for endoscopic resection will be eligible for enrollment. Participants will be randomly assigned in a 1:1 ratio to undergo either T-ESD or C-ESD. In the T-ESD group, a traction device will be used during submucosal dissection to improve visualization of the submucosal layer, whereas conventional ESD will be performed without routine use of a traction device. The primary outcome is resection speed, calculated as the resected specimen area divided by the submucosal dissection time. Secondary outcomes include total procedure time, submucosal dissection time, en bloc and R0 resection rates, resection margin status, procedure-related adverse events, length of hospital stay, time to diet resumption, and unplanned emergency department visits or readmissions. The study is designed as an exploratory pilot trial to estimate the efficacy, safety, and variability of traction-assisted ESD and to provide preliminary data for the design of a future larger multicenter randomized trial.
Adults aged 19 years or older. [+5]
Suspected muscularis propria invasion, lymph node metastasis, or distant metasta... [+9]