Modified Cap-assisted Endoscopic Mucosal Resection and Endoscopic Submucosal Dissection for Small Rectal Neuroendocrine Tumors Less Than 1 cm: a Muticenter Randomized Noninferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rectal Neuroendocrine Tumor
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 102
- Primary Endpoint
- histological complete resection
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
Investigators aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with ESD for the treatment of small rectal neuroendocrine tumors (NETs) in six tertiary hospitals in China.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age from 18 to 75 years;
- •With a high suspicion or evidence of rectal NET assessed using EUS or colonoscopy;
- •With tumor size ≤10 mm assessed by colonoscopy;
- •Plan to receive mEMR-C or ESD treatment and provide written informed consent;
Exclusion Criteria
- •Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
- •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;
- •Rectal NET with lymph node metastasis or distant metastasis;
- •Received resection of rectal neuroendocrine tumor by other surgical procedures;
- •Multiple rectal neuroendocrine tumors;
- •Vulnerable groups such as pregnant women or patients with mental disorders;
- •Poor compliance, unable to cooperate with treatment.
Outcomes
Primary Outcomes
histological complete resection
Time Frame: within 14 days after procedure
complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.
Secondary Outcomes
- en bloc resection(intraoperative)
- success rate of operation(intraoperative)
- complications(within 14 days after procedure)
- operation time(intraoperative)
- histopathologic grade(within 14 days after procedure)
- hospitalization cost(within 14 days after procedure)
- length of stay(within 14 days after procedure)
- operation cost(within 14 days after procedure)