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Traction-Assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors
Sponsor: Pusan National University Hospital
Summary
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.
Official title: Traction-assisted Versus Conventional Endoscopic Submucosal Dissection for Rectal Neuroendocrine Tumors: A Prospective Randomized Study
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2026-10-01
Completion Date
2027-12-31
Last Updated
2026-09-30
Healthy Volunteers
No
Conditions
Interventions
Traction-Assisted Endoscopic Submucosal Dissection
After submucosal injection and mucosal incision, a standardized traction device will be applied to the lesion to provide traction and improve visualization of the submucosal layer.
Conventional Endoscopic Submucosal Dissection
After submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device