Dresler 2005.
Methods | Multi‐centre RCT comparing talc poudrage with talc slurry pleurodesis in MPE. Both groups received 4 g ‐ 5 g sterile talc intrapleurally (USA) | |
Participants | Inclusion criteria: history of malignancy (all tumour types), pleural effusion requiring sclerosis, ECOG performance status 0‐2, life expectancy > 2 months, ability to undergo general anaesthesia Exclusion criteria: pregnancy, previous intrapleural therapy or radiation therapy encompassing the entire hemithorax, changes in systemic therapy within two weeks, chylous or bilateral effusions requiring therapy 501 participants randomised |
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Interventions | TS Group: talc administered as a slurry in 100 ml saline through a chest tube at the bedside TTI Group: talc insufflated during thoracoscopy in the operating room |
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Outcomes | Primary endpoint: the percentage of patients whose lung initially re‐expanded > 90% and who had a successful pleurodesis at 30 days after treatment (defined according to cvhest x‐ray (CXR) criteria) Secondary endpoint: time to recurrence of effusion; frequency of complications and toxicities; ability to re‐expand the lung as assessed by CXR; oain; patient satisfaction; quality of life (QOL). |
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Notes | People with trapped lung excluded from analysis Included in network meta‐analysis for pleurodesis efficacy, mortality, pain and fever. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation lists |
Allocation concealment (selection bias) | Low risk | Computer‐generated randomisation lists |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not possible to blind the study due to the nature of the interventions (talc poudrage vs talc slurry) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not stated if radiological assessment was blinded. QOL and complications may be affected by lack of patient and personnel blinding |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Missing data accounted for and balanced between the treatment arms (10 in slurry group and 9 in thoracoscopy group excluded as ineligible or participant withdrew consent; 33/163 slurry participants and 25/177 thoracoscopy participants died within 30 days of randomisation) |
Selective reporting (reporting bias) | Low risk | All outcomes reported on |
Other bias | Low risk | Trapped lung defined by different means in the two treatment arms, which may have effected their primary endpoint. However, this does not have an impact on the pleurodesis success rates |