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

Not Applicable

Recruiting

• Conditions: Rectal Neuroendocrine Neoplasm
• Interventions: Procedure: lateral pelvic lymph node dissection

• Registration Number: NCT06279299
• Lead Sponsor: National Cancer Center, China

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.

Detailed 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.

Study Timeline

• Study Start: 2022-08-01
• Status Verified: 2024-02
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-26
• Last Update Submitted: 2024-02-26
• Study First Posted: 2024-02-28
• Last Update Posted: 2024-02-28
• Primary Completion: 2028-08-01
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lateral Pelvic lymph node dissection	lateral pelvic lymph node dissection	After performing TME surgery, further conduct lateral pelvic lymph nodes dissection.

Primary Outcome Measures

Name	Time	Method
The rate of lateral pelvic lymph node metastasis	up to 14 days	The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.

Secondary Outcome Measures

Name	Time	Method
The rate of lymph node metastasis	up to 14 days	The rate of lymph node metastasis = lymph node metastasis cases/all cases.
Radical resection (R0)	up to 14 years	R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy
Overall survival rate	three years	The time from diagnosis to (for any reason) death.
Disease-free survival rate	three years	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.
Locoregional recurrence free survival rate	three year	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.

Trial Locations

Locations (1)

National Cancer Center; 🇨🇳 Beijing, Beijing, China