NCT03279419

Brief Summary

This is a feasibility study, to assess if thermal imaging and/or near infrared imaging will be useful in identifying changes in the peripheral circulation in patients with different stages of liver disease. The aim of this study is to use new and advanced thermal imaging techniques to identify changes in the peripheral circulation and hand temperature in patients with liver disease. These changes could be used as a non-invasive marker of the severity and progression of liver disease. Thermal imaging will also be used to assess the changes in the peripheral vasculature with the use of terlipressin, a drug used as treatment for specific complications of liver disease. Patients with acute or chronic liver disease from any aetiology will be recruited, along with patients without liver disease as healthy controls. Patients with disease or on drugs known to affect the peripheral vasculature will be excluded. All studies will be performed in a ward setting in the Royal Infirmary of Edinburgh. The subjects will be required for up to three sessions, each lasting 30 minutes. The session will involve static thermal images being taken, and video images of the hands warming up after being cooled for 30 seconds in water at a temperature of 7 degrees Celsius. If the patient is receiving terlipressin therapy, static images will be taken before, during and after terlipressin therapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
2 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 18, 2024

Status Verified

June 1, 2024

Enrollment Period

Same day

First QC Date

September 8, 2017

Last Update Submit

June 17, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in peripheral vasculature as assessed by thermal imaging

    2 years

Secondary Outcomes (1)

  • Changes in peripheral vasculature in response to terlipressin therapy.

    2 years

Study Arms (2)

Liver disease

15 patients with acute or chronic liver disease of any aetiology. Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling. Patient may or may not be receiving terlipressin therapy.

Diagnostic Test: Thermal imaging

Normal

15 patients without liver disease, and without any other disease or drug known to affect the peripheral circulation. Serial static images to be taken at up to 3 time points using thermal imaging camera. Video images using thermal camera will be used to capture warming of one hand after cooling.

Diagnostic Test: Thermal imaging

Interventions

Thermal imagingDIAGNOSTIC_TEST

Use of thermal imaging camera to capture images of peripheral vasculature (hands).

Liver diseaseNormal

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients aged 18-70 with acute or chronic liver disease

You may qualify if:

  • diagnosis of chronic liver disease (any stage)
  • diagnosis of acute liver disease (any aetiology)

You may not qualify if:

  • on drugs known to affect peripheral circulation
  • conditions known to affect peripheral circulation e.g. Raynauds

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univerity of Edinburgh and NHS Lothian

Edinburgh, United Kingdom

Location

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2017

First Posted

September 12, 2017

Study Start

September 1, 2019

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

June 18, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations