A randomised controlled trial to determine whether the use of indwelling pleural catheters in conjunction with talc slurry is superior to using an indwelling pleural catheter alone, in patients with malignant pleural effusion.

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; MedDRA version: 14.1 Level: PT Classification code 10035605 Term: Pleural mesothelioma malignant advanced System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: LLT Classification code 10035606 Term: Pleural mesothelioma malignant localised System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10061352 Term: Pleural neoplasm System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (in; MedDRA version: 14.1 Level: LLT Classification code 10066721 Term: Pleural effusion recurrent System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 14.1 Level: PT Classification code 10035607 Term: Pleural mesothelioma malignant recurrent System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1 Level: PT Classification code 10035598 Term: Pleural effusion System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Malignant pleural effusions; MedDRA version: 14.1 Level: LLT Classification code 10035608 Term: Pleural metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2012-000599-40-GB
• Lead Sponsor: orth Bristol NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-05-28
• Study Completion: 2016-12-09
• Last Update Posted: 30 April 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 154

Inclusion Criteria

1.Symptomatic malignant pleural effusion, agreed at appropriate local / regional MDT to require IPC, defined as pleural fluid in the context of: a.Histocytologically proven pleural malignancy, OR b.Otherwise unexplained pleural effusion in the context of clinically proven cancer elsewhere, OR c.Radiologically proven pleural malignancy as diagnosed in normal clinical practice on thoracic CT in the absence of histocytological proof 2.Expected survival greater than 2 months 3.Written informed consent to trial participation.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

1. Age < 18 years. 2. Females who are pregnant or lactating. 3. Patient unable to provide informed consent. 4. Previous attempts at pleurodesis on same side as effusion requiring management. 5. Previously documented adverse reaction to talc or lidocaine. 6. Community services unable to drain indwelling pleural catheter at least twice per week. 7. Evidence of extensive lung entrapment on CXR or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis or IPC insertion. 8. Other contraindication to indwelling pleural catheter insertion 9. Patient has no access to a telephone

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified