Terra 2009.
| Methods | Single centre RCT evaluating VATS talc poudrage and talc slurry in malignant pleural effusion (Brazil) | |
| Participants | Inclusion: biopsy or cytology proven MPE (all cell types); recurrent and symptomatic effusion; chest radiograph confirming lung expansion of > 90% after thoracentesis; Karnofsky PS ≥ 70 Exclusion: comorbidities that preclude GA; bleeding disorders; massive thoracic skin infiltration; active infection; refusal to sign informed consent 60 participants randomised |
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| Interventions | One dose of 5 g non‐calibrated talc given intrapleurally to both trial groups. Post procedure care and analgesia the same for the two groups. No suction used in either group. Drain removed when < 200 ml/24 hr drainage, or after 10 days if drain volume too high, participants were discharged with the drain in situ and a Heimlich valve VATS group: VATS performed under general anaesthesia, followed by talc poudrage. 28 Fr chest drain inserted at end of procedure Talc slurry group: 28 Fr chest drain inserted under local anaesthetic. Following day, talc suspended in 60 ml saline with 5 ml 2% lignocaine and instilled through chest drain. Clamped for one hour post procedure |
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| Outcomes | Lung expansion on CT measured on a 3‐point scale at baseline, 1, 3 and 6 months Clinical efficacy (success defined as no need for a new pleural procedure due to symptoms and radiological effusion recurrence) Quality of Life Safety Survival Chest drain duration Length of hospital stay Perioperative complications |
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| Notes | Raw data for survival, pleurodesis rates at certain time points, intervention rates at certain time points and QOL data not presented People with trapped lung excluded from trial entry Pleurodesis success rate defined using symptoms and radiology Study authors contacted for further information, but no reply Included in network meta‐analysis for pleurodesis efficacy and fever |
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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) | Unclear risk | Not stated |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind due to nature of the interventions (talc poudrage vs talc slurry) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Symptom recurrence, quality of life, inpatient stay and adverse event reporting could be biased by lack of blinding. Interpretation of CTs was done by two blinded observers, however pleurodesis efficacy was defined by need for repeat intervention |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow up |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | No other biases identified |