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.
This study is a prospective single-arm clinical study. 30 patients with rNENs undergoing TME are planned to be included in the study. The purpose of this study is to investigate the metastatic status of lateral pelvic lymph nodes in (rNENs) undergoing laparoscopic TME. The primary endpoint is the rate of lateral pelvic lymph nodes metastasis. The primary hypothesis was the rate of lateral lymph node metastasis is underestimated in rNENs undergoing TME, necessitating concurrent lateral Pelvic lymph node dissection. This study seeks to report for the first time the true status of lateral pelvic lymph node metastasis in these patients. In addition, the proportion of patients with radical resection (R0), surgical complication profile, and quality of life (QoL) are also secondary endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Following 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.
National Cancer Center
Beijing, Beijing Municipality, China
RECRUITINGThe rate of lateral pelvic lymph node metastasis
The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
Time frame: up to 14 days
The rate of lymph node metastasis
The rate of lymph node metastasis = lymph node metastasis cases/all cases.
Time frame: up to 14 days
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.
Time frame: three years
Overall survival rate
The time from diagnosis to (for any reason) death.
Time frame: three years
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.
Time frame: three year
Radical resection (R0)
R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy
Time frame: up to 14 years
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