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.
Patients diagnosed with or strongly suspected of having a rectal neuroendocrine tumor on colonoscopy.
Lesion size generally 15 mm or less, without suspected muscularis propria invasion on endoscopy and, when clinically indicated, endoscopic ultrasonography.
No suspected lymph node metastasis or distant metastasis based on abdominal/pelvic imaging or clinical assessment.
Suspected muscularis propria invasion, lymph node metastasis, or distant metastasis on endoscopy, endoscopic ultrasonography, imaging studies, or clinical assessment.
Lesion size greater than 15 mm, or a lesion considered by the investigator to require surgical treatment rather than endoscopic resection.
Conditions that make safe endoscopic submucosal dissection difficult, including inadequate bowel preparation.
Uncontrolled bleeding tendency, severe thrombocytopenia, or uncorrectable coagulation disorder.
Parallel
Traction-Assisted Endoscopic Submucosal Dissection
Procedure/SurgeryAfter 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
Procedure/SurgeryAfter submucosal injection, mucosal incision and submucosal dissection will be performed using conventional endoscopic submucosal dissection techniques without use of a traction device
Resection speed
Resection speed will be calculated as the resected specimen area (mm²) divided by the submucosal dissection time (min). The resected specimen area will be calculated using the ellipse formula: π × (major axis/2) × (minor axis/2). Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion. The outcome will be expressed as mm²/min.
Total Procedure Time
Total procedure time will be measured from the start of the initial lesion marking to complete resection of the lesion and will be expressed in minutes.
Submucosal Dissection Time
Submucosal dissection time will be measured from the start of submucosal dissection to complete resection of the lesion and will be expressed in minutes.
Traction Application Time
Time during which the traction device is applied during the ESD procedure in participants assigned to the traction-assisted ESD group, expressed in minutes.
En Bloc Resection Rate
The proportion of participants in whom the target lesion is resected in a single piece.
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