Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Not Applicable

Not yet recruiting

• Conditions: Rectal Neuroendocrine Tumor

• Registration Number: NCT05429216
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Status Verified: 2022-05
• Study Start: 2022-06
• Study First Submitted: 2022-06-17
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-07-01
• Primary Completion: 2023-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 102

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
histological complete resection	within 14 days after procedure	complete single-piece (en bloc) resection of the targeted lesion with horizontal and vertical free margins.

Secondary Outcome Measures

Name	Time	Method
en bloc resection	intraoperative	complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
success rate of operation	intraoperative	the proportion of patients whose tumors were successfully resected in each group
complications	within 14 days after procedure	perforation or hemorrhage during or after operation.
operation time	intraoperative	the time required to complete the procedure, was taken from the installation of the snare in the mEMR-C or the first submucosal injection in ESD to the end of complete resection of the targeted area or a failure or complication of the procedure which required discontinuation
histopathologic grade	within 14 days after procedure	NET grade 1, NET grade 2, NET grade 3, and NEC
hospitalization cost	within 14 days after procedure	represent the hospital's costs of being hospitalized
length of stay	within 14 days after procedure	calculated from the day of admission to day of discharge
operation cost	within 14 days after procedure	the cost of mEMR-C or ESD procedures, except the cost of other endoscopic procedures