A randomized trial comparing longstanding indwelling pleural catheters with pleurodesis as a frontline treatment for malignant pleural effusion.

• Conditions: Malignant pleural effusionIPC (indwelling pleural catheter)Talc pleurodesisMaligne pleuravochtVerblijfsdrainTalk pleurodese

• Registration Number: NL-OMON21466
• Lead Sponsor: Antoni van Leeuwenhoekziekenhuis (NKI-AVL), Amsterdam, The Netherlands

Brief Summary

A final report will be prepared for publication in peer reviewed journals.<br> Authorship will include investigators who have recruited at least 10% of the total number of evaluable patients and investigators who participated significantly to the translational research.<br> The authors sequence should usually reflect the input (like the number of evaluable patients enrolled) of/by the respective investigator.<br> Draft versions of abstracts or manuscripts must be made available to the co-authors before any presentation of results or submission for publication.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

1. Symptomatic pleural effusion;

2. Any histologically or cytologically proven malignancy;

Exclusion Criteria

1. Other causes of pleural effusion than malignancy;

2. Previous chemical or surgical pleurodesis;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by th Modified Borg scale.

Secondary Outcome Measures

Name	Time	Method
1. Number of emergency presentations at the outpatient clinic for reasons of symptomatic MPE after completion of the treatment;<br /><br>2. Number of interventions for MPE after completion of the MPE treatment;<br /><br>3. The overall time of hospitalization because of MPE;<br /><br>4. Patient reported dyspnoea and thoracic pain, directly following catheter placement and 3 and 6 months after randomization;<br /><br>5. Quality of Life;<br /><br>6. The treatment outcome at 1,3 and 6 months;<br /><br>7. Overall treatment costs in relation to MPE;<br /><br>8. Adverse Events;<br /><br>9. Overall survival;<br /><br>10. Detection of prognostic markers for the outcome of the intervention;<br /><br>11. Development of a clinical decision rule for treatment of MPE.