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naVIGation Invitations Liver surveillANce upTake

naVIGation Invitations Liver surveillANce upTake

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06635694
Acronym
VIGILANT
Enrollment
652
Registered
2024-10-10
Start date
2025-02-27
Completion date
2027-08-19
Last updated
2026-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hep B, Hepatocellular Carcinoma, Liver Cirrhosis

Brief summary

This study aims to evaluate the efficacy of Patient Navigators and mailed surveillance invitations on attendance of Hepatocellular Carcinoma (HCC) ultrasound surveillance appointments. The investigators hypothesise that mailed invitations and Patient Navigators will improve attendance at HCC surveillance appointments and increase the proportion of patients diagnosed at an early stage, compared with a control group receiving usual care.

Detailed description

Hepatocellular carcinoma (HCC) is the third leading cause of cancer-related death worldwide. Despite advances in treatment options, prognosis remains worrying, with 5-year survival rates remaining less than 20%. Surveillance for HCC involves six-monthly ultrasounds (US) of the liver and has been demonstrated to increase rate of early diagnosis, which translates to improved survival. However, the uptake of HCC surveillance is low internationally; in Western countries, only 20% of patients eligible for HCC surveillance receive a surveillance test. The current provision of HCC surveillance in the UK is ad hoc: eligible patients have six-monthly ultrasound requested by their clinician (usually a gastroenterologist, hepatologist or hepatology clinical nurse specialist). Patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test. Work with focus groups suggests lack of knowledge and fear are barriers to HCC surveillance attendance. Previous research has shown that patient navigation increased HCC surveillance uptake in an American population. However, there has been no research on interventions aimed at improving surveillance uptake in the UK population. The study predicts that the mailed invitations and Patient Navigators will improve patient attendance at HCC surveillance and increases the number of patients diagnosed with early-stage HCC, compared with usual care.

Interventions

None listed

Sponsors

RM Partners
CollaboratorUNKNOWN
Imperial College London
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 18 years of age or older * ECOG performance status of 0-2 * Eligible for HCC surveillance as defined by NICE and EASL criteria * Child Pugh A or B cirrhosis * Child Pugh C cirrhosis AND on liver transplant waiting list * High risk chronic hepatitis B

Exclusion criteria

* Previous or current diagnosis of HCC * Child Pugh C cirrhosis * Frailty (Clinical Frailty Scale \>7) * Previous liver transplant

Design outcomes

Primary

MeasureTime frame
Proportion of patients in each arm attending HCC surveillance regularly2 years
Attendance rates at 6-months intervals2 years

Secondary

MeasureTime frame
Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC2 years
Cost of intervention compared to standard of care2 years

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026