Fan 1994

Methods	Randomised trial comparing parenteral nutrition to no parenteral nutrition in patients hospitalized for resection of hepatocellular carcinoma. Geographical location Hong Kong. Study published 1994.
Participants	Inclusion criteria: Potentially resectable hepatocellular carcinoma. Exclusion criteria: None cited. 150 patients initially randomised, but 26 dropped out because metastatic disease found at time of surgery, leaving 124 patients (109 men/15 women, median age 54).
Interventions	Intervention group received parenteral nutrition (35% branched‐chain amino acids [1.5 gm/kg], intravenous dextrose and lipid [30 kcal/kg], vitamins, minerals/day) provided for 12 hours at night for 7 days preoperatively and for 7 days postoperatively as continuous infusion with 1.75 liter/d fluid restriction; Controls received usual diet preoperatively, 5% dextrose in normal saline postoperatively. Both groups received cefotaxime at time of anesthesia, normal diet preoperatively, and 25 gm intravenous albumin X 5d postop Duration 14 days.
Outcomes	Mortality, appearance ascites/gastrointestinal bleeding/encephalopathy, infections, median duration hospitalization, postoperative complications (total/intra‐abdominal/pneumonia/wound), median body weights, median triceps skinfold thickness, median midarm circumference. Adverse event recorded for parenteral nutrition group, but no evidence that similar complications were sought in control arm. Bilirubin only reported as "no difference".
Category of study	Parenteral nutrition/surgical (hepatocellular carcinoma resection).
Sample size calculation	Planned to reduce mortality by 50% and needed 60 patients per group.
Full paper or abstract only	Full paper.
Notes	E‐mail sent to Dr Fan on September 13, 2011 (stfan@hku.hk). No response has been received as of March 20, 2012.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Only states "randomly assigned".
Allocation concealment (selection bias)	Unclear risk	No details.
Blinding (performance bias and detection bias) All outcomes	High risk	Not blinded.
Incomplete outcome data (attrition bias) All outcomes	Low risk	11 dropouts in parenteral nutrition group and 15 in control group for metastatic disease (all accounted for).
Selective reporting (reporting bias)	Low risk	Mortality and morbidity outcomes reported.
Other bias	Unclear risk	More patients in parenteral nutrition group retained > 10% indocyanine green at 15 minutes (difference in baseline characteristics); funding source not reported.
Intent to treat analysis	High risk	Could not be done.
Baseline imbalance?	High risk	Parenteral nutrition patients may have been less ill.
Early stopping?	Low risk	Achieved planned number.