Surgery for rectal neuroendocrine tumors with lymph node dissection

Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision

This study is testing whether removing lymph nodes during surgery for rectal neuroendocrine tumors helps improve outcomes for patients and better understand the spread of the disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: National Cancer Center, China (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06279299 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the metastatic status of lateral pelvic lymph nodes in patients with rectal neuroendocrine neoplasms undergoing laparoscopic total mesenteric excision. It is a prospective single-arm study that plans to include 30 patients, aiming to determine the rate of lateral lymph node metastasis, which is hypothesized to be underestimated. The study will also assess the proportion of patients achieving radical resection, surgical complications, and quality of life outcomes. The findings could provide critical insights into the necessity of concurrent lymph node dissection during surgery.

Who should consider this trial

Good fit: Ideal candidates include patients with biopsy-proven rectal neuroendocrine neoplasms who meet specific tumor size and staging criteria.

Not a fit: Patients with complete intestinal obstruction or significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve surgical outcomes and survival rates for patients with rectal neuroendocrine neoplasms by ensuring comprehensive treatment of lymph node metastasis.

How similar studies have performed: While this approach is novel in the context of rectal neuroendocrine neoplasms, similar studies in other cancer types have shown success in addressing lymph node metastasis.

Eligibility criteria

Inclusion Criteria:

1. Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
2. 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.
3. Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
4. Written informed consent;

Exclusion Criteria:

1. Complete intestinal obstruction;
2. Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
3. 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；
4. Pregnancy or breastfeeding;
5. Alcohol abuse or drug addiction;
6. Concurrent uncontrolled medical condition;

Where this trial is running

Beijing, Beijing Municipality

• National Cancer Center — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Yueyang Zhang, M.D.

Conditions Rectal Neuroendocrine Neoplasm