Surgery for rectal neuroendocrine tumors with lymph node dissection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Cancer Center
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Yueyang Zhang, M.D.
• Email: yyzhang0129@163.com
• Phone: +8613552910035

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.