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

NCT ID: NCT06980571

Last Updated: 2025-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency ablation

50 patients randomised to radiofrequency ablation technique of liver resection

Group Type ACTIVE_COMPARATOR

radiofrequency ablation

Intervention Type DEVICE

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

CUSA

50 patients having liver resection randomised to CUSA

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiofrequency ablation

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* any adult patient listed for liver resection giving informed consent

Exclusion Criteria

* children, non-consent and diminished responsibility
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Barts & The London NHS Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert R Hutchins, MB BS MS FRCS

Role: PRINCIPAL_INVESTIGATOR

Royal London Hospital

Locations

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Royal London Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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P3/04/Q0605/31

Identifier Type: -

Identifier Source: org_study_id

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