Debulking surgery and hyperthermic chemotherapy for pleural mesothelioma: a pilot study.
Not Applicable
Completed
- Conditions
- Malignant pleural mesotheliomaCancer
- Registration Number
- ISRCTN12709516
- Lead Sponsor
- niversity of Catania
- Brief Summary
2021 Preprint results in https://www.medrxiv.org/content/10.1101/2021.11.27.21265291v1 Preprint results (added 10/08/2022) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37292347/ (added 02/01/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 27
Inclusion Criteria
1. Proven or suspected mesothelioma attending the Policlinico mesothelioma outpatient clinic
2. Patients that have given verbal and written consent to participant
3. Patients with pleural tumour and with associated pleural effusion that are fit enough for VATS pleurectomy/decortication
4. Patients attending Morgani clinic and University of Palermo that are undergoing talc pleurodesis
Exclusion Criteria
1. Unfit for a VATS procedure
2. Previously attempted pleurodesis
3. Without a pleural effusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participants quality of life will be assessed by the Symptoms and Quality of Life: European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire at baseline and at 3, 6 and 12 months.
- Secondary Outcome Measures
Name Time Method <br> 1. Survival rates of participants will be measured using personal interview or phone calls throughout the whole study period<br> 2. Length of hospital stay will be assessed by case report forms throughout study period during the hospitalisation<br> 3. Complications from the procedure will be assessed by case report forms (CRF) at baseline, 3, 6 and 12 months<br> 4. Recurrence of pleural effusion will be assessed by plain chest radiograph at 3, 6 and 12 months<br>