A prospective study to appraise the role of Immunological Biomarkers to predict the post operative outcomes of Epithelial Ovarian Carcinoma patients undergoing Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- CRS and HIPEC have a definitive role in the management of Epithelial Ovarian Cancers and CRP Kinetics help to predict postoperative morbid events or sub optimal surgery, compared to only WBC (Total Leukocyte) Counts.
研究概览
简要总结
With emerging developments in Oncology, Ovarian Carcinoma has been rationalized to be treated with CRS and HIPEC since most of the disease has a significant burden of Peritoneal spread (75%), wherein localized tumour resection and heated chemotherapy aids to vanquish the localized peritoneal disease. AIIMS is an apex institute and tertiary care referral centre catering to people all over India. This study is unique and aims to provide insight into the demographic profile and surgical outcomes in Epithelial Ovarian Cancer patients in India. Like all extensive surgeries CRS and HIPEC require meticulous post-operative care, not only due to the complexity of the surgery but also because the patients undergoing the surgery suffer from a number of comorbidities that may jeopardize the outcomes of the surgery.
Early detection of postoperative complications is important to avoid delays in management. However, in patients treated with CRS and HIPEC, the clinical detection of these complications is not always easy, and there are no documented or established clinical or biochemical markers to support the detection of post- operative outcomes, the results re purely subjective on the part of the treating surgeon’s suspicion. C-reactive protein (CRP) has been reported as a potential tool for predicting postoperative complications. The intensity of the inflammatory event influences the amount of CRP produced.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Female
入选标准
- •Patient’s requiring Upfront Cytoreductive Surgery and Interval Cytoreduction after Chemotherapy
- •Cytology or Biopsy proven Epithelial Ovarian malignancies
- •Localized Metastasis on Imaging (CECT scans will be the most commonly used investigation, as per institutional protocol)
- •Good Performance status (KPS-100-40 or ECOG -0-2)
- •Age >18 yrs < 70 years (extremes of age is to be avoided due to anticipation of the morbidity of the surgery)
- •Preexisting co-morbid conditions that DONOT preclude CRS and HIPEC
- •ASA I to III.
排除标准
- •Patient NOT consenting for Cytoreductive Surgery and HIPEC
- •Co morbidities that are a constant threat to the patient’s life
- •Poor performance Status and ASA IV and V
- •Study drop out.
结局指标
主要结局
CRS and HIPEC have a definitive role in the management of Epithelial Ovarian Cancers and CRP Kinetics help to predict postoperative morbid events or sub optimal surgery, compared to only WBC (Total Leukocyte) Counts.
时间窗: 1 week
次要结局
- Post Operative Complications and Morbid Surgical Events, including 30 and 90 days Morbidity(90 days)