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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNational Cancer Center, China

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • lateral pelvic lymph node dissection

    Procedure/Surgery

    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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Lateral Pelvic lymph node dissectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The 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

Secondary outcomes

1

The rate of lymph node metastasis

The rate of lymph node metastasis = lymph node metastasis cases/all cases.

Time frame
up to 14 days
2

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
3

Overall survival rate

The time from diagnosis to (for any reason) death.

Time frame
three years
4

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

Other outcomes

Sponsors and contacts

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