NCT06279299Recruiting
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
Source: ClinicalTrials.gov · Last updated 28 Feb 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in rectal neuroendocrine neoplasms (rNENs) undergoing laparoscopic total mesenteric excision (TME). The hypothesis is that the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 19 Feb 2024
- Start date
- Aug 2022
- Primary completion date
- Aug 2028
- Lead sponsor
- National Cancer Center, China
- Diseases
- Neuroendocrine tumours
- NCT number
- NCT06279299
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Aug 2022 to the primary completion date, Aug 2028
- 1 site in 1 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
- Significant organ dysfunction or other significant diseases, including clinically relevant coronary artery disease, cardiovascular disease, or myocardial infarction within the 12 months before enrollment; severe neurological or psychiatric history; severe infection; active disseminated intravascular coagulation;
- Alcohol abuse or drug addiction;
- Concurrent uncontrolled medical condition;
Other illness
- Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
Other
- Complete intestinal obstruction;
- Pregnancy or breastfeeding;
Who the study is looking for
- Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
- Meets any one of the following conditions:
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is greater than 2cm.
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and the clinical staging is T2 or higher.
- Preoperative imaging examinations reveal that the maximum diameter of the tumor is between 1-2cm and is categorized as Grade 3 differentiation.
- Recurrence after local excision under endoscopy.
- Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
- Written informed consent;
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.