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Trial Title:
Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
NCT ID:
NCT06279299
Condition:
Rectal Neuroendocrine Neoplasm
Conditions: Official terms:
Neoplasms
Neuroendocrine Tumors
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
lateral pelvic lymph node dissection
Description:
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.
Arm group label:
Lateral Pelvic lymph node dissection
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.
Criteria for eligibility:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
National Cancer Center
Address:
City:
Beijing
Zip:
100000
Country:
China
Status:
Recruiting
Contact:
Last name:
Haitao Zhou, M.D.
Phone:
+8613381167333
Email:
zhouhaitao01745@163.com
Contact backup:
Last name:
Yueyang Zhang, M.D.
Phone:
+8613552910035
Email:
yyzhang0129@163.com
Start date:
August 1, 2022
Completion date:
August 1, 2028
Lead sponsor:
Agency:
National Cancer Center, China
Agency class:
Other
Source:
National Cancer Center, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279299
