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

NCT06279299 | Recruiting

• 1 other identifier: LLND
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectal Neuroendocrine Neoplasm

Outcome Measures

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.

  up to 14 days

Secondary Outcomes (5)

• The rate of lymph node metastasis

  up to 14 days

• Disease-free survival rate

  three years

• Overall survival rate

  three years

• Locoregional recurrence free survival rate

  three year

• Radical resection (R0)

  up to 14 years

Study Arms (1)

Lateral Pelvic lymph node dissection

EXPERIMENTAL

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

Procedure: lateral pelvic lymph node dissection

Interventions

lateral pelvic lymph node dissection PROCEDURE

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.

Lateral Pelvic lymph node dissection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
• 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.
• Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
• Written informed consent;

You may not qualify if:

• 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;
• Alcohol abuse or drug addiction;
• Concurrent uncontrolled medical condition;

Sponsors & Collaborators

• National Cancer Center, China: lead

Study Sites (1)

National Cancer Center

Beijing, Beijing Municipality, 100000, China

RECRUITING

Study Officials

• Haitao Zhou

  National Cancer Center, China

  STUDY CHAIR

Central Study Contacts

Yueyang Zhang, M.D.

CONTACT

+8613552910035; yyzhang0129@163.com

Zheng Xu, M.D.

CONTACT

+8613141127297; 1206164395@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 28, 2024
• Study Start: August 1, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)