To compare the palliative efficacy of talc pleurodesis with the indwelling catheter
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint
• Patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by
the Modified Borg scale
Secondary outcome
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
Background summary
Patients with malignant pleural effusion (MPE) have a dismal prognosis. Pleural
fluid drainage is often necessary because of the symptoms. Talc pleurodesis has
become the method of choice to prevent recurrences. Recent intention-to-treat
analysis showed that outcome of pleurodesis is poor. There are no reliable
clinical factors that can be used to predict treatment outcome upfront.
Indwelling catheters form an alternative palliative intervention and provide us
with the opportunity to evacuate the pleural effusion on demand at home with a
minimal of hospitalizations.
Study objective
To compare the palliative efficacy of talc pleurodesis with the indwelling
catheter
Study design
Prospective multicenter randomized trial
Intervention
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. Patients can be randomized
for the standaard arm (talc pleurodesis) or the experimental arm (indwelling
pleural catheter).
Patient, randomized for the standaard arm, pleurodesis will be performed
according to the Dutch consensus guideline [4] and all patients will be
hospitalized for intercostal catheter placement.
Patients, randomized for the experimental arm, an IPC will be placed,
preferably under ultrasound guidance. Hospitalization is not warranted.
Study burden and risks
not applicable
Plesmanlaan 121
1066 CX Amsterdam
NL
Plesmanlaan 121
1066 CX Amsterdam
NL
Listed location countries
Age
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
other causes of pleural effusion than malignancy
previous chemical or surgical pleurodesis
impaired immunity: leucopenia <2.0 x 109/L, high dose corticosteriods (>=1mg/kg)
thrombocytopenia (< 50 x 109/L)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL32135.031.10 |