Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: modified double snare assisted endoscopic mucosal resection, endoscopic submucosal dissection.
- Who it may be relevant to
- Registry conditions: Rectal Neuroendocrine Tumors. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Procedure modified double snare assisted endoscopic mucosal resection
A polypectomy snare (resection snare) was placed outside of the endoscope. After approaching the lesion, a second polypectomy snare (capture snare) was inserted through the biopsy channel of the endoscope to grasp and lift the lesion. The snare preloaded outside of the endoscope was released, passed through the capture snare and positioned below the capture snare to grasp the base of the lesion. Once the lesion was securely grasped, it was resected by resection snare to achieve en bloc resection - Procedure endoscopic submucosal dissection
The procedure includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife (such as Dual knife, Golden knife or Kunpeng knife, etc.) , hemostasis and sealing of the wound. Traction is allowed during the operation.
Primary outcome measures
- complete resection [Time frame: Day 30]
Secondary outcome measures (6)
- En bloc resection [Time frame: Day 30]
- operation success rate [Time frame: Periprocedural]
- operation time [Time frame: Periprocedural]
- Postoperative hospital stay [Time frame: through study completion, an average of 30 days]
- operation-related expenses [Time frame: through study completion, an average of 30 days]
- Average hospitalization expenses [Time frame: through study completion, an average of 30 days]
Eligibility criteria
Inclusion criteria
- Typical rectal neuroendocrine tumors by endoscopy (within 15cm from the anal verge, yellowish subepithelial elevation with a smooth surface, and dilated blood vessels in some areas).
- The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment.
- Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment.
- Patients can understand and sign the informed consent.
Exclusion criteria
- Poor coagulation function(PT>15 seconds or APTT>45 seconds or INR>2.0)
- With severe cardiovascular or cerebrovascular diseases and cannot tolerate operation( with a history of stroke or myocardial infarction within the past month or with severe heart failure and cardiac function grade III)
- Indication of metastasis by preoperative imaging examinations
- With more than or equal to 2 rectal neuroendocrine tumors
- With other complications that are not suitable for this study by multidisciplinary team assesment
- Cases of recurrence after operation for neuroendocrine tumors
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07373015 · 2025-0755 · 2025-LCYJ-MS-12