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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lateral Pelvic lymph node dissection | Experimental | After performing TME surgery, further conduct lateral pelvic lymph nodes dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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: â‘ 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; â‘¡ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of lymph node metastasis | The rate of lymph node metastasis = lymph node metastasis cases/all cases. | up to 14 days |
| Disease-free survival rate | 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. |
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Inclusion Criteria:
Biopsy proven rectal neuroendocrine neoplasm (neuroendocrine tumor and carcinoma);
Meets any one of the following conditions:
Eastern Cooperative Oncology Group(ECOG) performance score ≤ 1;
Written informed consent;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yueyang Zhang, M.D. | Contact | +8613552910035 | yyzhang0129@163.com | |
| Zheng Xu, M.D. | Contact | +8613141127297 | 1206164395@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Haitao Zhou | National Cancer Center, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Recruiting | Beijing | Beijing Municipality | 100000 | China |
Participants' data are only allowed to be used for the analysis of this study and are not authorized to be shared with other researchers.
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|
| three years |
| Overall survival rate | The time from diagnosis to (for any reason) death. | three years |
| Locoregional recurrence free survival rate | 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. | three year |
| Radical resection (R0) | R0 resection rate is R0 resection probability of radical surgery in patients with locally advanced rectal cancer after neoadjuvant therapy | up to 14 years |