Preliminary Study on the Metastatic Rate and Clinical Significance of the Anterior Leaf of Vesicouterine Ligament in Early Stage Cervical Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- Metastatic rate of the anterior leaf of vesicouterine ligament
研究概览
简要总结
The purpose of this study is to preliminarily explore the metastatic rate and clinical significance of the anterior leaf of vesicouterine ligament resection for early stage cervical cancer, so as to further improve the postoperative quality of life of patients and reduce the incidence of postoperative urinary complications.
详细描述
The patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the same surgical team at the Department of Gynecological Oncology, Sun Yat-sen Memorial Hospital, Sun Yat-Sen University, were included. According to the resection range of the anterior leaf of vesicouterine ligament (VUL), patients were divided into type C resection group (near the bladder wall) and B type resection group (above the ureter). The anterior leaf of the VUL in the type C resection group was sent to pathological biopsy separately, and the metastasis rate was further clarified by the pathological "ultrastaging" method. By comparing the clinicopathological characteristics of patients with metastasis and non-metastasis, the potential risk factors of VUL metastasis were analyzed. The oncological outcomes of patients with different resection range of the anterior VUL were compared. At the same time, the Functional Assessment of Cancer Therapy-Cervical（FACT-Cx）cervical cancer patient quality of life score table was used to evaluate cervical cancer patients after surgery. The relevant factors that may affect the quality of life score are included in the multiple linear regression analysis to obtain independent risk factors that affect the quality of life of the patient after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of squamous, adenocarcinoma, or adenosquamous cervical carcinoma (even neuroendocrine or clear cell carcinoma)
- •Radiographically confirmed tumor limited to the cervix or upper third vagina, but without evidence of lymph node metastasis
- •Stage IA2-IIA2 ( FIGO 2018)
- •Treated initially or just underwent cervical conization before
- •Underwent the abdominal type C (Q-M classification) radical hysterectomy with pelvic lymph node dissection by the same team
- •Underwent the bilateral type C AL-VUL resection during the surgery
- •The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
排除标准
- •Not stage IA2-IIA2 ( FIGO 2018)
- •History of abdominal or pelvic radiotherapy
- •Evidence of metastatic disease detected by PECT, MRI or CT
- •The surgeon evaluated the patient as unsuitable for abdominal radical hysterectomy or the patient as refusing abdominal surgery
- •Patients with other mailgnant tumors except cervical cancer
- •Incompetence of the clinical, surgical and pathological data
结局指标
主要结局
Metastatic rate of the anterior leaf of vesicouterine ligament
时间窗: 1 year (Postoperative pathological confirmation date)
The metastasis rate of anterior leaf of VUL (%) = (case number of positive metastatic lesion detected by H\&E staining + case number of positive metastatic lesion diagnosed by "ultrastaging") / Total number of the patients with cervical cancer who underwent abdominal radical hysterectomy（type C）plus pelvic lymph node dissection by the samesurgical team ×100%
次要结局
- Incidence of postoperative adjuvant therapy in patients with metastasis in the anterior leaf of VUL(1 year after surgery)
- Incidence of postoperative urinary dysfunction in two groups(1 year after surgery)
- Postoperative quality of life scores in two groups(1，2，3 years after surgery)
- DFS(3 years after surgery)