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Trial Title:
VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
NCT ID:
NCT05840029
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
ovarian cancer stage III, IV; VATS, CT staging
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
VIDEO-ASSISTED THORACOSCOPIC SURGERY
Description:
A minimally invasive approach, to not only drain the pleural effusion but also evaluate
macroscopic pleural disease and, when possible, resect gross tumor.
Arm group label:
Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding.
Arm group label:
Group B: Patients who will proceed into debulking surgery based on VATS finding.
Other name:
VATS
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.
Criteria for eligibility:
Study pop:
Patients with advanced ovarian cancer at gyneoncology department will be enrolled
Sampling method:
Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
80 Years
Locations:
Facility:
Name:
Alexandria University
Address:
City:
Alexandria
Zip:
21131
Country:
Egypt
Start date:
June 1, 2021
Completion date:
April 30, 2023
Lead sponsor:
Agency:
Alexandria University
Agency class:
Other
Source:
Alexandria University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05840029
