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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34219

Enrollment

120

Registered

2010-08-18

Start date

2011-01-31

Completion date

Unknown

Last updated

2024-08-12

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

Conditions

malignant pleural effusion

Interventions

The first treatment for all patients is the therapeutic thoracentesis. Patients with recurrence of symptomatic MPE and fulfilling in- and exclusion criteria are candidates for the randomized trial. P

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: symptomatic pleural effusion any histologically or cytologically proven malignancy written informed consent recurrence of pleural effusion within 6 months after last therapeutic thoracentesis * written informed consent (part 2)

Exclusion criteria

Exclusion criteria: other causes of pleural effusion than malignancy previous chemical or surgical pleurodesis impaired immunity: leucopenia =1mg/kg) thrombocytopenia (

Design outcomes

Primary

Measure	Time frame
Primary endpoint • Patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by the Modified Borg scale	—

Secondary

Measure	Time frame
Secondary endpoints: • The number of emergency presentations or presentations at the outdoor clinic for reasons of symptomatic MPE after completion of the treatment • The number of interventions for MPE after completion of the MPE treatment • The overall time of hospitalization because of MPE • Patient reported dyspnoea and thoracic pain, directly following catheter placement, and 3 and 6 months after the randomization • Quality of Life • The treatment outcome at 1, 3 and 6 months • Overall treatment costs in relation to MPE • Adverse events • Overall survival • Detection of prognostic markers for the outcome of the intervention • Development of a clinical decision rule for treatment of MPE	—

Measure

Time frame

Secondary endpoints: • The number of emergency presentations or presentations at the outdoor clinic for reasons of symptomatic MPE after completion of the treatment • The number of interventions for MPE after completion of the MPE treatment • The overall time of hospitalization because of MPE • Patient reported dyspnoea and thoracic pain, directly following catheter placement, and 3 and 6 months after the randomization • Quality of Life • The treatment outcome at 1, 3 and 6 months • Overall treatment costs in relation to MPE • Adverse events • Overall survival • Detection of prognostic markers for the outcome of the intervention • Development of a clinical decision rule for treatment of MPE

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)