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Comparision of Safety and Efficacy Between Modified Double Snare Assisted EMR (mDS-EMR) and ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm: a Prospective Non-inferiority Randomized Controlled Study
The aim of this study is evaluating and safety and efficacy between the modified double snare EMR and ESD. It is intended to prove that for rectal neuroendocrine tumors within 1 cm, the complete resection rate of the mDS-EMR is not inferior to that of ESD, but may with shorter operation time, lower complication rate and lower treatment cost.
A prospective, single-center, randomized controlled non-inferiority trial was designed to compare the safety and efficacy of modified double snare EMR (mDS-EMR) with endoscopic submucosal dissection (ESD) for the resection of rectal neuroendocrine tumors. The study have 4 main research contents. 1, Whether the resection effect of mDS-EMR is not inferior to that of ESD, and the treatment effect is evaluated by the complete resection rate (R0 resection rate). 2, Whether the operation time of mDS-EMR is significantly shorter than that of ESD. 3, To compare the safety between mDS-EMR and ESD, and whether the mDS-EMR can reduce the risk of intraoperative and postoperative adverse events. 4, To compare the postoperative hospital stay, surgical costs and hospitalization costs between mDS-EMR and ESD.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Start Date
January 1, 2026
Primary Completion Date
May 31, 2028
Completion Date
June 30, 2028
Last Updated
January 28, 2026
118
ESTIMATED participants
modified double snare assisted endoscopic mucosal resection
PROCEDURE
endoscopic submucosal dissection
PROCEDURE
Lead Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Data Source & Attribution
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