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Debulking surgery and hyperthermic chemotherapy for pleural mesothelioma: a pilot study.

Prospective randomised controlled trial of video-assisted thoracoscopic Cytoreductive Pleurectomy (VATS-CP) with Hyperthermic Intraoperative Chemotherapy (HIC) compared to talc pleurodesis (TP) in patients with Malignant pleural Mesothelioma (MPM): a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12709516
Enrollment
24
Registered
2017-01-23
Start date
2014-07-01
Completion date
Unknown
Last updated
2024-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant pleural mesothelioma Cancer Malignant pleural mesothelioma

Interventions

Participants receive either debulking and hyperthermic intraoperative intrathoracic chemotherapy (HITHOC) or talc pleurodesis depending on which trial participating centre they attend. This is determi

Sponsors

University of Catania
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: 1. Unfit for a VATS procedure 2. Previously attempted pleurodesis 3. Without a pleural effusion

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
1. Survival rates of participants will be measured using personal interview or phone calls throughout the whole study period 2. Length of hospital stay will be assessed by case report forms throughout study period during the hospitalisation 3. Complications from the procedure will be assessed by case report forms (CRF) at baseline, 3, 6 and 12 months 4. Recurrence of pleural effusion will be assessed by plain chest radiograph at 3, 6 and 12 months

Countries

Italy

Contacts

Public ContactMarcello Migliore
mmiglior@hotmail.com+39 487 007 229

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026