VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

Ovarian Cancer Clinical Trial

Official title:

THE ROLE OF VIDEO-ASSISTED THORACOSCOPIC SURGERY IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05840029
• Other study ID #: VATS and ovarian cancer
• Status: Active, not recruiting
• Start date: June 1, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: November 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ovarian cancer is the seventh most common cancer and the fifth leading cause of death in women worldwide. About 70% of patients with epithelial ovarian cancer present with advanced disease which will require a combination of cytoreductive surgery and chemotherapy to give them their best chance of long term survival.The presence of macroscopic pleural disease-especially if undetected and unresected after primary debulking surgery-may alter treatment decision-making and markedly affect survival. Video-Assisted Thoracoscopic Surgery (VATS) allows surgeons, through a minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor. Few studies reported that VATS altered the therapeutic management in ovarian cancer patients leading to an upstaging or down-staging when compared to the CT staging. Therefore, this study will prospectively assess the role of VATS in the diagnosis and management of supradiaphragmatic disease as well as evaluate the impact of VATS findings on the decision of surgical management in patients with advanced ovarian cancer FIGO (The International Federation of Gynecology and Obstetrics) stage III/IV.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 68
• Est. completion date: April 30, 2023
• Est. primary completion date: January 30, 2023
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• FIGO stage III/IV ovarian cancer with or without pleural effusion

Exclusion Criteria:

1. Previously treated ovarian disease.

2. Patient unfit for single lung ventilation.

3. Patients with previous lung surgery.

4. Patients with possible intrapleural adhesions.

5. Patients who had pulmonary resection.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Procedure:
• VIDEO-ASSISTED THORACOSCOPIC SURGERY
A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs	Comparison between the Chest-CT results in preoperative evaluation of supra-diaphragmatic disease will be compared to the intra-operative VATS evaluation results to evaluate the role of the VATS in those patients	3 weekS
Secondary	The rate of change in the treatment plan according to VATs results	The number of patients that will receive different treatment plan after detection of intrathoracic disease using VATs	1 week