Luh 1992.
Methods | Single centre RCT of OK‐432 and mitomycin C pleurodesis in lung cancer patients with MPE (Taiwan) | |
Participants | Inclusion criteria: histo/cyto proven MPE due to lung cancer; effusion requiring repeated thoracentesis; ECOG performance score 0‐3 Exclusion criteria: previous anticancer chemotherapy within four weeks; previous radiation therapy to the ipsilateral chest within four weeks; concomitant systemic chemo or radio‐therapy; history or evidence of penicillin allergy 55 participants randomised |
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Interventions | All participants hospitalised and a chest drain or pigtail catheter inserted into effusion. Drainage until < 200 ml/day. Tube clamped for one hour after drug administration. Drug administration repeated weekly for four weeks or until effusion resolved ok‐432 group: 1 KE intrapleurally Mitomycin C: 8 mg in 30 ml water intrapleurally |
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Outcomes | Pleurodesis success at four weeks (defined as 'complete response' (CR) (no fluid accumulation and participants free of symptoms), 'partial response' (PR) (recurrence of effusion < 50% of original effusion volume, not symptomatic and no need for thoracentesis for symptom relief) or 'failure' (recurrence of effusion > 50% of the original volume, symptomatic and need for thoracentesis to relieve symptoms)) Survival Effusion‐free period |
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Notes | People with trapped lung included in the study For this review, PR & CR counted as pleurodesis successes Not included in network meta‐analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Sealed envelopes |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No mention of whether the study was blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participants excluded due to early death, both in OK‐432 arm |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported |
Other bias | Low risk | No other biases identified |