PARA AORTIC LYMPH NODAL MAPPING IN EPITHELIAL OVARIAN CANCER A PROSPECTIVE COHORT STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- para-aortic nodal involvement
研究概览
简要总结
Goal of surgery in ovarian cancer is to optimally resect out all the disease sites within the intra-peritoneal cavity and lymphadenectomy is an integral part of it. Rate of lymph nodal metastasis has been seen to range from 20-40% in early ovarian cancers to upto 50-80% in advanced stages. National Comprehensive Cancer Network (NCCN) currently recommends para-aortic node dissection (PAND) up to the level of Inferior Mesenteric Artery (at least) or renal vessels (preferrable) along with bilateral pelvic node dissection in newly diagnosed EOC involving pelvis / upper abdomen with
However, para-aortic nodal dissection is associated with a high morbidity including increased operative time, blood loss, lymphocyst, lymphedema etc. Severity of complications related to lymphadenectomy will also depend on the level of nodal dissection. The extent and template of nodal dissection is not well defined in ovarian cancer, largely due to lack of dedicated audit of the involved nodal basins in these subsets of the patients.
Present study is intended to map out the pattern of the lymph nodes involved para-aortic region in ovarian cancer. Such study should help the surgical oncologist to decide the extent of the lymph node dissection in relation to stage of the disease and associated risk benefit ratio.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patients with epithelial ovarian cancers who undergo systematic retroperitoneal lymph node dissection as part of their cytoreductive surgery (Primary/Interval/Secondary) at AIIMS Rishikesh & AIIMS Jodhpur
- •Patients aged 18 to 80 years
- •Willing to participate in the study (written informed consent).
排除标准
- •1.Previous retroperitoneal lymph node dissection/surgery for any reason 2.Non curative surgery 3.Incomplete/Inadequate retroperitoneal lymph node dissection (for any reason) as deemed by the operating surgeon 4.Concurrent second malignancy.
结局指标
主要结局
para-aortic nodal involvement
时间窗: at baseline
次要结局
- Radiological and Pathological correlation of para-aortic nodal metastases in ovarian cancer patients(at baseline)
- To determine 30 day surgical morbidity(30 days)
- To determine the quality of life outcomes using EORTC QLQ-C30 questionnaire(30 days)