Luo 2019.
Methods | Study design: Randomised clinical trial Study duration: March 2015 to March 2017 Duration of follow‐up: 1 year Setting: Hospital |
Participants | Inclusion criteria were in line with the diagnostic criteria of middle and advanced liver cancer, diagnosed as liver cancer by pathology, impossibility in radical resection, no combined distant metastasis; stable vital signs, normal coagulation mechanism, normal liver and kidney functions, complete clinical data, completing one year's postoperative follow‐up Exclusion criteria: with combined severe mental illness, severe heart, lung, kidney disease, accompanied with other malignancies and haematological diseases, pregnant and lactating women with abnormal coagulation mechanisms, with possibility of radical resection, poor compliance and failure to complete follow‐up Age (mean ± SD, range): 58.34 ± 2.95 years, 35‐73 years Male (n/total): 52/90 |
Interventions | TACE + HIFU group (n = 45): HIFU was performed 2‐4 weeks after TACE treatment. The parameters of HIFU tumour treatment system were: frequency 0.8 MHz, focal length 150 mm and treatment duration 4946‐16223 s. The therapeutic range and therapeutic dose were adjusted by monitoring B‐mode ultrasound images during the treatment. Forty‐five patients were treated with HIFU for at least 2 times and up to 6 times, with an average of 3.16 times. TACE group (n = 45): The chemotherapy drugs included 5‐fluorouracil 1.0 g and epirubicin 30 mg (10 mg of which was mixed with an appropriate amount of ultra‐liquid iodised oil to form emulsion). The dose of lipiodol emulsion varied depending on the size of the lesion and intraoperative tolerability of the patient, with an average dose at 10.5 mL. TACE treatment was performed 1‐2 times depending on the patient's tolerability, with intervals of 3‐4 weeks. |
Outcomes | Tumour response: After six months of treatment, the efficacy was evaluated according to WHO criteria. Liver function Adverse events Recurrence rate |
Notes | Country of study: China
Source of funding: None There was insufficient information available to satisfactorily determine the method of randomisation and the study data could not be verified. We have attempted to contact the study authors for more information, but so far, we have not been successful in doing this. |