Clinical trial · Interventional
Endoscopic Resection for Small Rectal Neuroendocrine Tumors
Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
- 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)
In previous single center study, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic submucosal dissection (ESD) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) and mEMR-C was inferior to ESD for the treatment of small rectal NETs (≤10 mm), as it has shorter operation times and lower hospitalization costs. However, a multicenter randomized controlled trial is needed to prove the universality and generality of these findings.
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 Tumor | Rectal Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ESD procedure | Procedure | — | UNRESOLVED |
| mEMR-C procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- mEMR-C group
- description
- In mEMR-C group, enrolled patients will receive modified EMR-C without submucosal injection.
- interventionNames
- Procedure: mEMR-C procedure
- type
- ACTIVE_COMPARATOR
- label
- ESD group
- description
- In ESD group, enrolled patients will receive the standard treatment modality of ESD to remove the rectal NET
- interventionNames
- Procedure: ESD procedure
Primary outcomes (1)
- measure
- histological complete resection
- timeFrame
- within 14 days after procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 18 to 75 years; 2. With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy; 3. With tumor size ≤10 mm assessed by colonoscopy; 4. Plan to receive mEMR-C or ESD treatment and provide written informed consent; Exclusion Criteria: 1. Unable to tolerate ESD or MEMR-C as assessed by the research team of each center; 2. Complicated with serious diseases such as malignant tumor, which may lead to shorter life expectancy, the research team considers that it is not suitable for inclusion in the study after comprehensive evaluation; 3. Rectal NET with lymph node metastasis or distant metastasis; 4. Received resection of rectal neuroendocrine tumor by other surgical procedures; 5. Multiple rectal neuroendocrine tumors; 6. Vulnerable groups such as pregnant women or patients with mental disorders; 7. Poor compliance, unable to cooperate with treatment.
References
Publications (0)
Data not yet available