Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Pleural Effusion, Malignant

Pleural Effusion

Pleural Diseases

Respiratory Tract Diseases

Pleural Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Implantation of PleurX-Pleural catheter plus talc pleurodesis

talc pleurodesis, no implantation of PleurX-Pleural catheter

poudrage of 4 gr talc into the pleural cavity implantation of tunneled pleural catheter

VATS, Talc-Pleurodesis, tunneled pleural drainage

poudrage of 4 gr. talc into the pleural cavity no tunneled pleural catheter

VATS, Talc-pleurodesis

Hans Hoffmann, MD, PhD

An open randomized, prospective, single center; parallel group trial to compare efficiency and safety of PleurX-Pleural Catheter versus standard surgical treatment in patients with malignant pleural effusion and partial entrapment of the lung.

Patients with malignant pleural effusions undergo VATS-procedure. In the intraoperative finding of a partially entrapped lung, patients are randomized in 2 groups.

Arm 1: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery.

Arm 2: Insufflation of talc and insertion of a (standard) drainage which will be removed 4-7 days after surgery. Additionally, a subcutaneous tunneled catheter will be inserted and will remain in situ

Follow up period is 3 Months

Primary objective is the comparison of quality of life between the 2 arms.

Secondary objective is the reliability of the subcutaneous tunnelled catheter in practice as well as function and dysfunction of the drainage system. Clinical parameters (respiratory function measured as FEV1 and vital capacity, recurrent pleural effusion, infection, need for relief of effusion or pleuracentesis) are observed.

Tunneled Pleural Catheter in Partially Entrapped Lung

Randomized Trial of Tunneled Pleural Catheter Versus Standard Chest Tube in Management of Malignant Pleural Effusion in Patients With Partial Entrapment of the Lung

Heidelberg University

Head

Rare Diseases

Mesothelioma

Mesothelioma, Malignant

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Mesothelial

Lung Neoplasms

Lung Diseases

Malignant Mesothelioma

All Drugs and Chemicals

Amino Acids

Carbon-11 methionine

Methionine

No intervention

Egesta Lopci, MD

Prospective exploratory study specifically investigating the role of 11C-Methionine PET/CT imaging in patients affected by Malignant Pleural Mesothelioma (MPM) and candidate to pleurodesis.

This is a single-center, open-label study, lasting 36 months including an estimated period of 24 months for the enrollment and max 12 months of follow-up. All patients affected by MPM and referred to our Institution eligible for therapeutic pleurodesis and subsequent platinum- and pemetrexed-based chemotherapy will be enrolled. In all cases patients will be investigated with 11C-Methionine PET/CT and 18F-FDG PET/CT before talc pleurodesis, one week after and at the end of three cycles of chemotherapy.

A minimum number of 20 patients will be considered for the analysis.

11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)

Diagnostic and Prognostic Role of 11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM) and Candidate to Pleurodesis

Istituto Clinico Humanitas

Day-case IPC insertion. Attendance d10 for drainage, stitch removal and education in catheter care.

Hospital admission for chest drain insertion and suction if needed, plus talc pleurodesis by slurry or poudrage if \>75% of visceral and parietal pleura in direct contact on chest x-ray.

Indwelling Pleural Catheter

Talc Pleurodesis

Pyng Lee, MBBS, MRCP, MMED, FAMS, FCCP

Pyng Lee

Malignant pleural effusion (MPE) accounts for 50% of all pleural effusions and affects about 300,000 patients annually (UK and USA). Lung and breast cancers account for majority of malignant pleural effusions; 1 in 3 breast cancer, 1 in 4 lung cancer as well as \> 90% of patients with mesothelioma develop pleural effusions. Breathlessness from MPE is disabling and impairs quality of life. Median survival ranges between 4-6 months. Although thoracentesis provides effective symptom relief, most effusions recur and pleurodesis is the standard of care. Pleurodesis can be performed via chest tube or applied during pleuroscopy, and talc is the most effective agent. For successful pleurodesis to occur the underlying lung must expand after fluid drainage and trapped lung due to metastatic disease occurs up to 30%. Symptomatic patients require hospitalization for these procedures which are likely to fail if trapped lungs are encountered, and pose significant burden to health services. Tunneled indwelling pleural catheter (IPC) is emerging as a viable alternative which provides access to the pleural space for fluid drainage when breathlessness arise. IPC can be performed at ambulatory setting without hospital admission. Case series have demonstrated long-term safety of IPC even in patients undergoing chemotherapy with acceptable complication rates. By keeping the pleural cavity free of fluid, IPC has led to spontaneous pleurodesis in 50% of patients, which allows its removal. Presently IPC is indicated for trapped lung or when talc pleurodesis has failed. A randomised comparative trial with talc pleurodesis is necessary to determine role of IPC as first-line therapy of MPE, if IPC leads to reduction in hospitalizations, adverse events and healthcare costs, and if it improves quality of life. The multicenter trial randomizes symptomatic patients 1:1 to IPC or talc pleurodesis, and endpoints include hospitalization days till death or end of study, adverse events, quality of life, and healthcare costs.

Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management

A Multicentre Randomised Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis in Patients With a Malignant Pleural Effusion

National University Hospital, Singapore

A/Prof Lee Pyng

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tunneled Pleural Catheter in Partially Entrapped Lung	NCT00637676	Malignant Pleur...	VATS, Talc-Pleu... VATS, Talc-pleu...	18 Years -	Heidelberg University
11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)	NCT02519049	Mesothelioma, M...	No intervention	18 Years -	Istituto Clinico Humanitas
Multicentre Study Comparing Indwelling Pleural Catheter With Talc Pleurodesis for Malignant Pleural Effusion Management	NCT02045121	Pleural Effusio...	Indwelling Pleu... Talc Pleurodesi...	19 Years -	National University Hospital, Singapore
11C-Methionine PET/CT Imaging in Patients Affected by Malignant Pleural Mesothelioma (MPM)	NCT02519049	Mesothelioma, M...	No intervention	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for talc pleurodesis