VATS IN PATIENTS WITH ADVANCED OVARIAN MALIGNANCIES

NCT05840029 | Unknown

• 1 other identifier: VATS and ovarian cancer
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

ovarian cancer stage III, IV; VATS, CT staging

Outcome Measures

Primary Outcomes (1)

• Prediction of intrathoracic disease using chest-CT results compared to the standard reference results using VATs

  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 Outcomes (1)

• The rate of change in the treatment plan according to VATs results

  1 week

Study Arms (2)

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

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

Interventions

VIDEO-ASSISTED THORACOSCOPIC SURGERY PROCEDURE

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

Also known as: VATS

Group A: Patients who will get neoadjuvant chemotherapy based on VATS finding.; Group B: Patients who will proceed into debulking surgery based on VATS finding.

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with advanced ovarian cancer at gyneoncology department will be enrolled

You may qualify if:

• FIGO stage III/IV ovarian cancer with or without pleural effusion

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, 21131, Egypt

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Thoracic Surgery, Video-Assisted

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Thoracoscopy; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Video-Assisted Surgery; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Thoracic Surgical Procedures

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2023
• First Posted: May 3, 2023
• Study Start: June 1, 2021
• Primary Completion: January 30, 2023
• Study Completion: April 30, 2023
• Last Updated: May 3, 2023

Record last verified: 2022-11

Locations

EG (1)