Hunt.
Methods | Single centre randomised controlled trial. Generation of allocation schedule truly random. |
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Participants | 61 patients with unresectable liver metastases and no evidence of extrahepatic disease. Karnofsky score >60. Age 18‐75 years. Fit enough to undergo laparotomy. Patients excluded if extensive disease (jaundice, ascites, percentage liver replacement >75%) | |
Interventions | Hepatic artery injection of 5‐Fluorouracil (500mg) plus Degradable starch microspheres (300‐900mg). First course consisted of 4 injections on consecutive days. Each subsequent course consisted of 2 injections on consecutive days, repeated every 28 days. vs Hepatic artery embolisation vs No active therapeutic intervention. Symptomatic treatment provided where necessary | |
Outcomes | Overall survival, Extrahepatic disease, Toxicity, Complications | |
Notes | Analysis was by intention to treat. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Low risk | A ‐ Adequate |