VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

NCT ID: NCT05840029

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ovarian Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

VIDEO-ASSISTED THORACOSCOPIC SURGERY

Intervention Type PROCEDURE

A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.

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.

VIDEO-ASSISTED THORACOSCOPIC SURGERY

Intervention Type PROCEDURE

A minimally invasive approach, to not only drain the pleural effusion but also evaluate macroscopic pleural disease and, when possible, resect gross tumor.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VATS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexandria University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Alexandria University

Alexandria, , Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

VATS and ovarian cancer

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.