naVIGation Invitations Liver surveillANce upTake

NCT06635694 | Active Not Recruiting DMC

• 1 other identifier: 23HH8630
• Study Type: observational
• Target: 652
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Liver Cirrhosis; Chronic Hep B

Outcome Measures

Primary Outcomes (2)

• Attendance rates at 6-months intervals

  2 years

• Proportion of patients in each arm attending HCC surveillance regularly

  2 years

Secondary Outcomes (2)

• Proportion of patients in each arm diagnosed with HCC compared with late-stage HCC

  2 years

• Cost of intervention compared to standard of care

  2 years

Study Arms (2)

Usual Care

Responsible clinician will request surveillance imaging and ultrasound appointment will be booked using an automated call/recall system. A formal invitation to surveillance and an informational sheet will be sent by post to patient's home address, addressing concerns including fear, and FAQs e.g. duration of scan and level of discomfort. Patients will receive a reminder 2 weeks prior to their appointment. Results will be automatically sent to the relevant hepatology unit and GP. Patients will be informed of results by mail or through "patientknowsbest" app, and invited for repeat ultrasound in 6 months. Patients with abnormal results will be contacted by the direct care team to organise further investigations. Non-attendance will be followed by a further appointment letter/text. Patients who fail to attend 2 appointments will be contacted by the direct care team. Their reasons for non-attendance will be recorded and GP contacted.

Patient Navigator

Patients will receive usual care plus a scripted phone call from a Patient Navigator the week prior to the surveillance appointment to remind patients, offer to reschedule the appointment if the patient is unable to attend, and address any concerns about the appointment. All other procedures will be the same as usual care. Additionally, Navigators will call patients who have not attended surveillance imaging appointments to explore any barriers to attendance and how these might be addressed.

Eligibility Criteria

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

Study Population

Patients receiving 6-monthly ultrasound surveillance for HCC

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• RM Partners: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W12 0HS, United Kingdom

Location

Related Publications (1)

• Pandiaraja M, Qurashi M, Izadi H, Martinez M, Sharma R. Efficacy of mailed surveillance invitations and telephone patient navigation to improve hepatocellular carcinoma surveillance uptake: study protocol of VIGILANT-a single-centre, two-arm randomised controlled trial. BMJ Open. 2025 Jun 30;15(6):e097162. doi: 10.1136/bmjopen-2024-097162.

  PMID: 40588390 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Cirrhosis; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Chronic Disease; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2024
• First Posted: October 10, 2024
• Study Start: February 27, 2025
• Primary Completion (Estimated): August 19, 2027
• Study Completion (Estimated): August 19, 2027
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)