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Thermal Imaging in Liver Disease.

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ClinicalTrials.gov Identifier: NCT03279419
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Edinburgh

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.


Condition or disease Intervention/treatment
Liver Diseases Diagnostic Test: Thermal imaging

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Thermal Imaging of the Peripheral Vasculature in Liver Disease.
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Use of thermal imaging camera to capture images of peripheral vasculature (hands).

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




Primary Outcome Measures :
  1. Changes in peripheral vasculature as assessed by thermal imaging [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Changes in peripheral vasculature in response to terlipressin therapy. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients aged 18-70 with acute or chronic liver disease
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279419


Contacts
Contact: Mhairi Donnelly, MBChB 00447969824902 mhairi.donnelly@nhs.net

Locations
United Kingdom
Univerity of Edinburgh and NHS Lothian Recruiting
Edinburgh, United Kingdom
Contact: Chric Coner       chris.coner@ed.ac.uk   
Sponsors and Collaborators
University of Edinburgh

Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT03279419     History of Changes
Other Study ID Numbers: IRAS ID 189169
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases