Lateral Pelvic Lymph Node Dissection for Rectal Neuroendocrine Neoplasms Undergoing Laparoscopic Total Mesenteric Excision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The rate of lateral pelvic lymph node metastasis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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;
研究组 & 干预措施
Lateral Pelvic lymph node dissection
After performing TME surgery, further conduct lateral pelvic lymph nodes dissection.
干预措施: lateral pelvic lymph node dissection (Procedure)
结局指标
主要结局
The rate of lateral pelvic lymph node metastasis
时间窗: up to 14 days
The rate of lateral pelvic lymph node metastasis = lateral pelvic lymph node metastasis cases/all cases.
次要结局
- Radical resection (R0)(up to 14 years)
- The rate of lymph node metastasis(up to 14 days)
- Overall survival rate(three years)
- Disease-free survival rate(three years)
- Locoregional recurrence free survival rate(three year)
研究者
Haitao Zhou
Clinical Professor
National Cancer Center, China