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

National Cancer Center, China

Status: Enrolling

Conditions: Rectal Neuroendocrine Neoplasm

Treatments: Procedure: lateral pelvic lymph node dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06279299

LLND

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Lateral Pelvic lymph node dissection

Experimental group

Description:

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

Treatment:

Procedure: lateral pelvic lymph node dissection