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. 2016 May 8;2016(5):CD010529. doi: 10.1002/14651858.CD010529.pub2

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
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
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
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