VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

Active, not recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: VIDEO-ASSISTED THORACOSCOPIC SURGERY

• Registration Number: NCT05840029
• Lead Sponsor: Alexandria University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2022-11
• Primary Completion: 2023-01-30
• Study First Submitted: 2023-04-21
• Study First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Study Completion: 2023-04-30
• Study First Posted: 2023-05-03
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 68

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding.	VIDEO-ASSISTED THORACOSCOPIC SURGERY	Patients will be considered to receive neoadjuvant chemotherapy if there is residual intrathoracic disease
Group B: Patients who will proceed into debulking surgery based on VATS finding.	VIDEO-ASSISTED THORACOSCOPIC SURGERY	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.

Primary Outcome Measures

Name	Time	Method
Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs	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

Secondary Outcome Measures

Name	Time	Method
The rate of change in the treatment plan according to VATs results	1 week	The number of patients that will receive different treatment plan after detection of intrathoracic disease using VATs

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt