Crnjac 2004.
| Methods | Single centre RCT comparing thoracoscopic mechanical pleurodesis (TMP) with talc slurry (Slovenia) | |
| Participants | Inclusion: breast carcinoma and a resulting morphologically confirmed MPE Exclusion: unfit for general anaesthetic (GA) 87 participants randomised |
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| Interventions | TMP arm: thoracoscopy (under GA) with adhesiolysis, pleural biopsy and scarification of the visceral and parietal pleura to induce bleeding. Chest tube inserted at the end of procedure Talc slurry arm: chest tube inserted under local anaesthetic. 5 g talc in 100 ml saline insufflated through chest tube Participants in both arms had the drain removed when < 100ml/24hour drainage |
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| Outcomes | Recurrence of effusion on chest x‐ray (CXR) at 1 day, 1 week, 1 month, 3 months and 6 months Duration of chest tube drainage Duration of hospitalisation Complications Mortality (30 days and 6 months) |
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| Notes | People with trapped lung not excluded. Pleurodesis success defined using CXR criteria alone Not included in network meta‐analysis |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not stated |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible to blind the study as comparing talc slurry with thoracoscopy |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Not stated whether radiological assessments were done in a blinded fashion. Complication reporting, time of tube drainage may be effected by lack of patient and personnel blinding. Mortality outcome not effected by lack of blinding |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis performed. Minimal missing data. 6/45 patients died within six months in TMP group vs 8/42 in talc slurry arm |
| Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
| Other bias | Low risk | No documentation of patient experience (e.g. QOL or degree of discomfort), relative costs or need for repeat pleural intervention Pleurodesis success defined using radiology only. Participants who did not have evidence of recurrence at death were classified as pleurodesis successes |