VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

April 21, 2023 updated by: Alexandria University

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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21131
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients with advanced ovarian cancer at gyneoncology department will be enrolled

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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.
Other Names:
  • VATS
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.
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.
Other Names:
  • VATS

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
3 weekS

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
The number of patients that will receive different treatment plan after detection of intrathoracic disease using VATs
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

January 30, 2023

Study Completion (Anticipated)

April 30, 2023

Study Registration Dates

First Submitted

April 21, 2023

First Submitted That Met QC Criteria

April 21, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 21, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

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

No

Studies a U.S. FDA-regulated device product

No

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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