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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06279299
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Cancer Center, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Haitao Zhou
Principal Investigator Affiliation	National Cancer Center, China
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rectal Neuroendocrine Neoplasm

Additional Details

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.

Arms & Interventions

Arms

Experimental: Lateral Pelvic lymph node dissection

After performing TME surgery, further conduct lateral pelvic lymph nodes dissection.

Interventions

Procedure: - lateral pelvic lymph node dissection

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.

Contact a Trial Team

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International Sites

National Cancer Center, Beijing, Beijing, China

Status

Recruiting

Address

National Cancer Center

Beijing, Beijing, 100000

Site Contact

Haitao Zhou, M.D.

[email protected]

+8613381167333

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