NCT05429216Not yet recruiting
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 · Last updated 1 Jul 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 102 (estimated)
- First submitted
- 17 Jun 2022
- Start date
- Jun 2022
- Primary completion date
- Dec 2023
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT05429216
What you commit to
- Study type: Interventional
- Planned participants: 102
- From Jun 2022 to the primary completion date, Dec 2023
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received resection of rectal neuroendocrine tumor by other surgical procedures;
Other illness
- 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;
- Vulnerable groups such as pregnant women or patients with mental disorders;
Other
- Unable to tolerate ESD or MEMR-C as assessed by the research team of each center;
- Rectal NET with lymph node metastasis or distant metastasis;
- Multiple rectal neuroendocrine tumors;
- Poor compliance, unable to cooperate with treatment.
Who the study is looking for
- 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;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.