- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05840029
VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
THE ROLE OF VIDEO-ASSISTED THORACOSCOPIC SURGERY IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Alexandria, Egypt, 21131
- Alexandria University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- FIGO stage III/IV ovarian cancer with or without pleural effusion
Exclusion Criteria:
- Previously treated ovarian disease.
- Patient unfit for single lung ventilation.
- Patients with previous lung surgery.
- Patients with possible intrapleural adhesions.
- Patients who had pulmonary resection.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding.
Patients will be considered to receive neoadjuvant chemotherapy if there is residual intrathoracic disease
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A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.
Other Names:
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Group B: Patients who will proceed into debulking surgery based on VATS finding.
Patients will be considered to be eligible for complete debulking, if VATS showed no intrathoracic tumor or if VATS achieves complete removal of tumor nodules through intraoperative frozen section histopathological examination.
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A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs
Time Frame: 3 weekS
|
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
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3 weekS
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of change in the treatment plan according to VATs results
Time Frame: 1 week
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The number of patients that will receive different treatment plan after detection of intrathoracic disease using VATs
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1 week
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VATS and ovarian cancer
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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