About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
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.
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
lateral pelvic lymph node dissection
Procedure/SurgeryFollowing the total mesorectal excision principle, the rectum and mesentery are removed, with careful protection of the pelvic autonomic nerves. After completing laparoscopic rectal resection, lateral lymph node dissection is performed. The lateral dissection follows these steps: ① Open the peritoneum at the bifurcation of the iliac vessels, dissect along the retroperitoneum adjacent to the ureter-bladder fascia, expose the lateral pelvic area, and carefully protect the ureter and hypogastric nerves. Open the peritoneum along the edge of the external iliac vessels close to the inguinal ligament, clear the lymphatic fatty tissue alongside the external iliac vessels along the edge of the iliopsoas and internal oblique muscles; ② After identifying the hypogastric nerve, dissect along the bladder-bladder fascia, separate the bladder and the fat tissue around the lateral pelvic space, completely remove the lymphatic tissue around the internal iliac vessels and hypogastric nerves.
Treatment groups
Trial outcomes
Primary outcomes
The rate of lateral pelvic lymph node metastasis
The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
Secondary outcomes
The rate of lymph node metastasis
The rate of lymph node metastasis = lymph node metastasis cases/all cases.
Disease-free survival rate
Disease-free survival (DFS) is a number that tells the chances of staying free of a disease or cancer after a particular treatment. It is the percentage of individuals in the treatment group who are likely to be free of the signs and symptoms of a disease after a specified duration of time.
Overall survival rate
The time from diagnosis to (for any reason) death.
Locoregional recurrence free survival rate
Locoregional Recurrence Free Survival is defined as the time interval between the day of diagnosis in the study and the date of local relapse/recurrence or regional relapse/recurrence whichever occurs first.
Sponsors and contacts
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