Randomised Prospective Study of CUSA Versus Radiofrequenc... | NCT06980571

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

NCT06980571

Sponsor

Barts & The London NHS Trust

Status

Completed

Last Update Posted

May 20, 2025Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Liver Disease

Interventions

radiofrequency ablation

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Nov 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 27, 2009

First Submission Date that Met QC Criteria

May 12, 2025

First Posted Date

May 20, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2025

Last Update Posted Date

May 20, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
radiofrequency ablation	Device	FDA approved intervention being compared with gold standard (most common intervention)	Radiofrequency ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood loss per cm squared of liver parenchyma cut through		operation date until three months from discharge

Secondary Outcomes

Measure	Description	Time Frame
mortality	incidence of post-operative complications measured over a thirty day period	inpatient and thirty day mortality

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

any adult patient listed for liver resection giving informed consent

Exclusion Criteria:

children, non-consent and diminished responsibility

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert R Hutchins, MB BS MS FRCS	Royal London Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal London Hospital		London		E1 1BB	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D008107	Liver Diseases
D006470	Hemorrhage

Ancestor Terms

ID	Term
D004066	Digestive System Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078703	Radiofrequency Ablation

Ancestor Terms

ID	Term
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided