Blood Tests of Immunological Biomarkers can predict the outcomes of Cytoreductive Surgery (Complete Tumor and Tumor Deposit Removal) and Hyperthermic Intraperitoneal Chemotherapy (Heated Chemotherapy in the abdomen during Surgery), in Ovarian Cancer patients

Not yet recruiting

• Conditions: Malignant neoplasm of unspecifiedovary,

• Registration Number: CTRI/2023/01/049023

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-01-14
• Study Start: 2023-01-16

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: Female
• Target Recruitment: 41

Inclusion Criteria

• Patient’s requiring Upfront Cytoreductive Surgery and Interval Cytoreduction after Chemotherapy 2.
• Cytology or Biopsy proven Epithelial Ovarian malignancies 3.
• Localized Metastasis on Imaging (CECT scans will be the most commonly used investigation, as per institutional protocol) 4.
• Good Performance status (KPS-100-40 or ECOG -0-2) 5.
• Age >18 yrs < 70 years (extremes of age is to be avoided due to anticipation of the morbidity of the surgery) 6.
• Preexisting co-morbid conditions that DONOT preclude CRS and HIPEC 7.
• ASA I to III.

Exclusion Criteria

• Patient NOT consenting for Cytoreductive Surgery and HIPEC 2.
• Co morbidities that are a constant threat to the patient’s life 3.
• Poor performance Status and ASA IV and V 4.
• Study drop out.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	1 week

Secondary Outcome Measures

Name	Time	Method
Post Operative Complications and Morbid Surgical Events, including 30 and 90 days Morbidity	90 days

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

All India Institute of Medical Sciences

🇮🇳Patna, BIHAR, India

Dr Shouptik Basu

Principal investigator

9153041506

shouptik10324@aiimspatna.org