Liver Disease
Conditions
Keywords
liver resection, blood loss, resection technique, CUSA, radiofrequency ablation, health economics, benign and malignant liver disease
Brief summary
The purpose of this study is to determine whether a particular method of operating on the liver is superior to the gold standard commonest technique. CUSA (ultrasonic agitation) will be compared to the newer heat coagulation technique (radiofrequency ablation) and comparisons of blood loss, transfusion requirements, complication rates, hospital stay, effect on liver function, health economics and death rate will be made. The groups will be assessed for comparability in terms of underlying disease, resection type, underlying concurrent illnesses, sex, age, background liver disease. Standardisations of the rest of the operation will be carried out including anaesthetic technique and fluid requirements will be assessed by oesophageal Doppler. 100 patients will be recruited.
Interventions
DEVICEradiofrequency ablation
FDA approved intervention being compared with gold standard (most common intervention)
Sponsors
Barts & The London NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* any adult patient listed for liver resection giving informed consent
Exclusion criteria
* children, non-consent and diminished responsibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Blood loss per cm squared of liver parenchyma cut through | operation date until three months from discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| mortality | inpatient and thirty day mortality | incidence of post-operative complications measured over a thirty day period |
Countries
United Kingdom
Outcome results
None listed