Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Barts & The London NHS Trust
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Blood loss per cm squared of liver parenchyma cut through
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •any adult patient listed for liver resection giving informed consent
Exclusion Criteria
- •children, non-consent and diminished responsibility
Arms & Interventions
Radiofrequency ablation
50 patients randomised to radiofrequency ablation technique of liver resection
Intervention: radiofrequency ablation (Device)
CUSA
50 patients having liver resection randomised to CUSA
Outcomes
Primary Outcomes
Blood loss per cm squared of liver parenchyma cut through
Time Frame: operation date until three months from discharge
Secondary Outcomes
- mortality(inpatient and thirty day mortality)