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. 2009 Jan 21;2009(1):CD006880. doi: 10.1002/14651858.CD006880.pub2

Arita 2005.

Methods Randomised clinical trial.
Generation of the allocation sequence: computerised minimisation process (adequate). 
 Allocation concealment: held by third party (adequate). 
 Blinding: inadequate. 
 Incomplete outcome data addressed:adequate. 
 Free from selective reporting: adequate. 
 Free from baseline imbalance bias: adequate. 
 Free from early stopping bias: adequate. 
 Free from sponsor bias: adequate.
Participants Country: Japan. 
 Number randomised: 80. 
 Median age: 66 (RFDS); 68 (clamp‐crush). 
 Females: 20 (25%). 
 Major liver resection: 20 (25%). 
 Chronic liver disease: 43 (53.8%). 
 Cirrhosis: 21 (26.3%).
Inclusion criteria
  1. Hepatic resection for hepatobiliary malignancy.

  2. Age 20 to 79 years.

  3. Platelet count more than 50000/ml.

  4. Prothrombin activity > 60% .

  5. Bleeding time < 5 min.


Exclusion criteria
Inflow occlusion at the hepatic hilum proved impossible at laparotomy.
Interventions Participants were randomly assigned to two groups.
Group 1: RFDS (n = 40) 
 Group 2: Clamp‐crush (n = 40).
Co‐interventions
  1. Vascular occlusion: intermittent PTC (15min +5 min) or hemihepatic vascular occlusion (30min + 5 min).

  2. Low CVP: not stated.

  3. Hypoventilation: not stated.

  4. IV agents to decrease blood loss: not stated.

  5. Management of raw surface: vessels larger than 1 mm in diameter were ligated and divided. Small vessels and minor oozing were dealt with by cauterization. Macroscopic bile leakage ‐ controlled by fine suturing; fibrin glue.

Outcomes The main outcome measures were peri‐operative mortality, peri‐operative morbidity, blood loss and transfusion requirements, liver function tests, transection speed, and hospital stay.
Notes We requested further information from the authors regarding some outcomes in December 2006. We were unable to obtain the information.
Risk of bias
Bias Authors' judgement Support for judgement
Adequate sequence generation? Low risk A ‐ Adequate ("The assignments were done by an internet‐accessed registration system administered by the independent randomization service")
Allocation concealment? Low risk A ‐ Adequate ("The assignments were done by an internet‐accessed registration system administered by the independent randomization service")
Blinding? 
 All outcomes High risk C ‐ Inadequate
Incomplete outcome data addressed? 
 All outcomes Low risk A ‐ Adequate
Review authors' comment: No post‐randomisation drop‐outs.
Free of selective reporting? Low risk A ‐ Adequate
Review authors' comment: All the important outcomes were reported.
Free of baseline imbalance bias? Low risk A ‐ Adequate
From from early stopping bias? Low risk A ‐ Adequate
Review author comment: The sample size calculations were reported and the calculated number of patients were recruited.
Free from academic bias? Low risk A ‐ Adequate
Review author comment: No previous publication or conference report of a similar trial by the trial author was identified.
Free from sponsor bias? Low risk A ‐ Adequate ("This work was supported by a grant from the Kanae Foundation for Life‐Socio‐medical service")