Zhong 2010.
| Methods | Trial design: randomised, multicentre, double‐blinded, placebo‐controlled clinical trial Mean follow‐up: not reported Study duration: not reported Language: English Type of information: abstract (abstract appears to present preliminary data for the first 182 participants randomised) Judgement on quality: unclear risk |
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| Participants | Setting: Shanghai First People's Hospital Allocation of participants: target enrolment of 300 participants, current participants not adequately reported (study ongoing) Sex ratio: total: not reported Intervention A: not reported Intervention B: not reported Mean age: total: not reported Intervention A: not reported Intervention B: not reported Indication (no. (%)): (hepatocellular carcinoma primary indication for all transplants) Hepatocellular carcinoma: total: not reported (100%), Intervention A: not reported (100%), Intervention B: not reported (100%) Type of donor: not reported Inclusion criteria: liver transplant recipients with hepatocellular carcinoma Exclusion criteria: death within 3 months of transplantation, inability to provide written informed consent prior to study entry |
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| Interventions | Intervention A: no intervention Intervention B: methylprednisolone 10 mg/kg intraoperatively and a further 10 mg/kg given over 1 week Concomitant immunosuppression: Tacrolimus/cyclosporine A: dose not reported (NOTE: published abstract reports use of cyclosporine A, register on clinicaltrials.gov reports use of tacrolimus) Basiliximab: 20 mg given twice (timings not reported) |
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| Outcomes | Mortality, graft loss, acute rejection, infection, bacterial infection, de novo diabetes mellitus, recurrent hepatitis B, hypertension, neurological complications, tumour size, tumour differentiation, histological staging of tumour, recurrence‐free survival | |
| Notes | Cross‐over between intervention arms: no Sample size calculation: not reported Sources of funding: Shanghai Jiao Tong University School of Medicine |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: Generation of randomisation sequence not described |
| Allocation concealment (selection bias) | Unclear risk | Comment: Allocation concealment not described |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: Blinding of participants and medical staff not described |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Blinding of outcome assessors not described |
| Incomplete outcome data (attrition bias) | Unclear risk | Comment: Number of withdrawals and reasons for withdrawal not reported, estimated enrolment not achieved and results only published in abstract |
| Selective reporting (reporting bias) | High risk | Comment: Results only published in abstract, graft survival not reported |
| Other bias | Unclear risk | Comment: No sample size calculation reported |
| Free of early stopping? | Unclear risk | Comment: Study only published in abstract |
| Free of baseline imbalance? | Unclear risk | Comment: Baseline characteristics not described, presence or absence of baseline imbalance not reported |
ABO: blood group ALT: alanine aminotransferase AST: aspartate aminotransferase BMI: body mass index CMV: cytomegalovirus GGT: gamma‐glutamyl transferase HBsAg: hepatitis B surface antigen HBV: hepatitis B virus HCC: hepatocellular carcinoma HCV: hepatitis C virus HDL: high density lipoprotein HIV: human immunodeficiency virus HSV: herpes simplex virus IgM: immunoglobulin M IVC: inferior vena cava LDL: low density lipoprotein MELD: model for end‐stage liver disease MMF: mycophenolate mofetil NAFLD: non‐alcoholic fatty liver disease RCT: randomised clinical trial