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

Recruiting now · Not applicable

Conditions studied: Rectal Neuroendocrine Neoplasm

In brief

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.

Key facts

Study ID

NCT06279299

Run by

National Cancer Center, China

People needed

30

Starts

2022-08-01

Expected to finish

2028-08-01

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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;

You may not qualify if…

• Complete intestinal obstruction;
• Hepatitis activity and peripheral neuropathy (such as peripheral neuritis, pseudo meningitis, motor neuritis, and sensory impairment);
• 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；
• Pregnancy or breastfeeding;
• Alcohol abuse or drug addiction;
• Concurrent uncontrolled medical condition;

Where it is running

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

Full record on ClinicalTrials.gov

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