Randomised Prospective Study of CUSA Versus Radiofrequency Ablation Technique in Liver Resections

NCT06980571 | Completed

• 1 other identifier: P3/04/Q0605/31
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Disease

Keywords

liver resection; blood loss; resection technique; CUSA; radiofrequency ablation; health economics; benign and malignant liver disease

Outcome Measures

Primary Outcomes (1)

• Blood loss per cm squared of liver parenchyma cut through

  operation date until three months from discharge

Secondary Outcomes (1)

• mortality

  inpatient and thirty day mortality

Study Arms (2)

Radiofrequency ablation

ACTIVE COMPARATOR

50 patients randomised to radiofrequency ablation technique of liver resection

Device: radiofrequency ablation

CUSA

NO INTERVENTION

50 patients having liver resection randomised to CUSA

Interventions

radiofrequency ablation DEVICE

FDA approved intervention being compared with gold standard (most common intervention)

Radiofrequency ablation

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any adult patient listed for liver resection giving informed consent

You may not qualify if:

• children, non-consent and diminished responsibility

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

Study Sites (1)

Royal London Hospital

London, E1 1BB, United Kingdom

Location

MeSH Terms

Conditions

Liver Diseases; Hemorrhage

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Robert R Hutchins, MB BS MS FRCS

  Royal London Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: May 20, 2025
• Study Start: June 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

GB (1)