Ishida 2006.
Methods | Single centre RCT of intrapleural cisplatin vsOK‐432 vs combination (Japan) | |
Participants | Inclusion criteria: symptomatic, histocytologically confirmed pleural malignancy secondary to Non‐small cell lung cancer(NSCLC), ECOG performance score 0‐3, adequate renal, haematological and cardiac function Exclusion Criteria: previous intrapleural therapy, trapped lung or atelectasis after chest tube inserted 49 participants randomised |
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Interventions | All participants underwent pleural fluid drainage via a 20 Fr chest tube. After administration of the allocated treatment, chest drain was clamped for six hours and then connected to 20 cm H2O suction. Drain removed when < 100 ml/day Cisplatin group: 50 mg cisplatin via chest tube on day 1 and 4 ok‐432 group: one dose of 5 KEOK‐432 via chest tube Combination group: 50 mg cisplatin on day 1 and 4, followed by 5 KEOK‐432 on day 7 |
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Outcomes | Effusion recurrence (as defined by a newly detected effusion needing drainage or occupying > 33% of pleural space on CXR); mortality; adverse events | |
Notes | people with trapped lung excluded from the study Study authors contacted for further information, but no response 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) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No mention of blinding but participants received different dosing regimes depending on study arm |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Adverse event reporting could be affected by knowledge of treatment allocation. Not stated whether CXR interpretation was performed in a blinded fashion for definition of pleurodesis efficacy |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of deaths clearly stated. If participants died, still included in analysis for pleurodesis success prior to death |
Selective reporting (reporting bias) | Low risk | All pre‐defined outcomes reported |
Other bias | High risk | Drain left in for different duration in the three groups. Steroids were given to participants who received cisplatin |