Clinical trial · Interventional
Modified Double Snare Assisted EMR (mDS-EMR) VS ESD for Rectal Neuroendocrine Tumors Smaller Than 1cm
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neuroendocrine Tumors | Rectal Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| endoscopic submucosal dissection | Procedure | — | UNRESOLVED |
| modified double snare assisted endoscopic mucosal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- ESD
- description
- The traditional ESD treatment method is adopted, which includes submucosal injection of normal saline and methylene blue suspension, cutting and dissection by mucosal incision knife, hemostasis and cliping of the wound. Traction is allowed during the operation.
- interventionNames
- Procedure: endoscopic submucosal dissection
- type
- EXPERIMENTAL
- label
- mDS-EMR
- description
- Modified double snare assisted EMR was used for treatment. Put the first snare for resecting outside the endoscope body. Then put the second snare at the base through the channel to tighten the lesion. Finally, place the first snare below the second one to tighten the lesion and perform electrically-assisted removal. Then, metal clips will be used to close the wound.
- interventionNames
- Procedure: modified double snare assisted endoscopic mucosal resection
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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). 2. The maximum diameter of the lesion is smaller than 1cm by preoperative endoscopic assessment. 3. Lesion is located within the mucosal and submucosal layer by preoperative endoscopic assessment. 4. Patients can understand and sign the informed consent. Exclusion Criteria: 1. Poor coagulation function(PT\>15 seconds or APTT\>45 seconds or INR\>2.0) 2. 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) 3. Indication of metastasis by preoperative imaging examinations 4. With more than or equal to 2 rectal neuroendocrine tumors 5. With other complications that are not suitable for this study by multidisciplinary team assesment 6. Cases of recurrence after operation for neuroendocrine tumors
References
Publications (0)
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