The observed improvement in palliative care (dyspnoea is the most prominent symptom) in the pleurodesis group is less than the improvement in the indwelling arm.
ID
Bron
Verkorte titel
Aandoening
Malignant pleural effusion
IPC (indwelling pleural catheter)
Talc pleurodesis
Maligne pleuravocht
Verblijfsdrain
Talk pleurodese
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by th Modified Borg scale.
Achtergrond van het onderzoek
Consecutive 120 patients with symptomatic MPE will be registered in part 1 (thoracentesis) of the study. 80 patients (of the 120) with recurrent symptomatic MPE will be asked to participate in a randomized trial comparing the standard talc pleurodesis (arm A) with the experimental treatment, the indwelling catheter (arm B). Primairy endpoint of the study is the patient reported dyspnoea at 4 to 6 weeks after the intervention, assessed by the Modified Bord scale.
Doel van het onderzoek
The observed improvement in palliative care (dyspnoea is the most prominent symptom) in the pleurodesis group is less than the improvement in the indwelling arm.
Onderzoeksopzet
1. First patient in 2010 Q3;
2. Final patient in 2012 Q1;
3. Data lock 2012 Q3;
4. Reporting 2013 Q1.
Onderzoeksproduct en/of interventie
1. Thoracentesis;
2. Talc pleurodesis;
3. Placement of indwelling pleural catheter.
Publiek
Plesmanlaan 121
M.M. Heuvel, van den
Amsterdam 1066 CX
The Netherlands
+31 (0)20 5122958
m.vd.heuvel@nki.nl
Wetenschappelijk
Plesmanlaan 121
M.M. Heuvel, van den
Amsterdam 1066 CX
The Netherlands
+31 (0)20 5122958
m.vd.heuvel@nki.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Symptomatic pleural effusion;
2. Any histologically or cytologically proven malignancy;
3. Written informed consent;
4. Recurrence of pleural effusion within 6 months after last therapeutic thoracentesis.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Other causes of pleural effusion than malignancy;
2. Previous chemical or surgical pleurodesis;
3. Impaired immunity: Leucopenia <2.0 x 109/L, high dose corticosteriods (>=1 mg/kg);
4. Thrombocytopenia (<50 x 109/L).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2410 |
| NTR-old | NTR2518 |
| CCMO | NL32135.031.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON34219 |
Samenvatting resultaten
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.