Endoscopic Resection for Small Rectal Neuroendocrine Tumors

Not Applicable

Not yet recruiting

• Conditions: Rectal Neuroendocrine Tumor

• Registration Number: NCT06901856
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief Summary

According to clinical practice and relevant retrospective research data, both modified cap-assisted endoscopic mucosal resection (mEMR-C) and endoscopic mucosal resection with a ligation device(ESMR-L) were reported to be effective for the treatment of small rectal neuroendocrine tumors (NETs) . However, there is a lack of multicenter prospective studies to evaluate the advantages and disadvantages of mEMR-C and mEMR-L. mEMR-C is the modified ESMR-L without submucosal injection.

Detailed Description

We aimed to conduct a muticenter randomized controlled trial to compare mEMR-C with mEMR-L for the treatment of small rectal neuroendocrine tumors (NETs) in ten tertiary hospitals in China.

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-30
• Last Update Posted: 2025-03-30
• Primary Completion: 2025-12
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Age from 18 to 80 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 mEMR-L treatment and provide written informed consent;

Exclusion Criteria

1. Unable to tolerate mEMR-L 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
success rate of operation	intraoperative	the proportion of patients whose tumors were successfully resected in each group
en bloc resection	intraoperative	complete single resection of the targeted lesion, irrespective of whether the basal and lateral tumor margins were infiltrated or undetermined
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
complications	within 14 days after procedure	perforation or hemorrhage during or after operation
length of stay	within 14 days after procedure	calculated from the day of admission to day of discharge
hospitalization cost	within 14 days after procedure	represent the hospital's costs of being hospitalized
operation cost	within 14 days after procedure	the cost of mEMR-C or mEMR-L procedures, except the cost of other endoscopic procedures
histopathologic grade	within 14 days after procedure	NET grade 1, NET grade 2, NET grade 3, and NEC