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Trial registered on ANZCTR


Registration number
ACTRN12619000081112
Ethics application status
Approved
Date submitted
27/11/2018
Date registered
21/01/2019
Date last updated
2/05/2019
Date data sharing statement initially provided
21/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of trans-jugular intrahepatic portosystemic shunts on muscle mass in chronic liver disease.
Scientific title
The impact of trans-jugular intrahepatic portosystemic shunts on body composition in decompensated cirrhosis: A prospective cohort study
Secondary ID [1] 296722 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cirrhosis 310579 0
portal hypertension 310580 0
sarcopenia 310581 0
Trans-jugular intrahepatic portosystemic shunt 310582 0
Condition category
Condition code
Oral and Gastrointestinal 309295 309295 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Musculoskeletal 309298 309298 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Adult patients with cirrhosis who have been referred for a trans-jugular, intrahepatic portosystemic shunt (TIPS) for clinical indications by their treating physician will be approached for participation in this research study. Baseline measures will be obtained prior to TIPS. These measures will be repeated at 3 months and 6 months after TIPS to assess changes in body composition. The trial will involve 6 months of follow up after TIPS.
Enrolment: A single slice from the third lumbar vertebrae will be used for a CT performed prior to TIPS (as part of standard of care). This will be analysed for lean muscle mass, subcutaneous adipose tissue and visceral adipose tissue using dedicated computer software.

At each appointment (baseline prior to TIPS, 3 months and 6 months post TIPS) Physical assessments (short Physical performance battery and fried frailty index) and clinical history and examination will also be performed (30 minutes). Patients will undergo blood tests (10minutes) and a test of cognitive function, Stroop Test (10minutes).

Prior to undergoing TIPS, patients will have had a CT abdomen performed to assist with TIPS planning as part of standard of care. A single slice of this scan at L3 level will be analysed using dedicated software to estimate lean muscle mass and visceral and subcutaneous adipose tissue. A further L3 single slice CT scan will be performed at 6 months after TIPS to assess for changes in these parameters (15min).
Intervention code [1] 313029 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308265 0
Skeletal muscle index as measured on a single slice CT at the 3rd lumbar vertebrae
Timepoint [1] 308265 0
CT scan prior to TIPS will be compared to a single slice scan taken at 6 months post TIPS
Secondary outcome [1] 354463 0
Handgrip strength as measured on the hand dynamometer
Timepoint [1] 354463 0
Baseline, 3 months and 6 months post TIPS
Secondary outcome [2] 354464 0
Liver Frailty Index, a measure of muscle strength, endurance and balance
Timepoint [2] 354464 0
0, 3 months and 6 months post TIPS
Secondary outcome [3] 354465 0
Short Physical Performance Battery, a test of physical strength and performance
Timepoint [3] 354465 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [4] 354466 0
Changes in hepatic encephalopathy, as measured by the Stroop Test
Timepoint [4] 354466 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [5] 354469 0
Caloric intake (Kcal/d) measured by a study specific instrument
Timepoint [5] 354469 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [6] 354470 0
Assess changes in immune function on a blood sample as measured by quantiferon monitor, a validated immune function assay
Timepoint [6] 354470 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [7] 354471 0
To assess changes in myostatin levels measured on serum samples
Timepoint [7] 354471 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [8] 354472 0
To assess changes in severity of liver disease measured by model for end stage liver disease (MELD) score
Timepoint [8] 354472 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [9] 354473 0
To assess changes in serum IGF-1
Timepoint [9] 354473 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [10] 365309 0
Changes in fasting lipid profile
Timepoint [10] 365309 0
0 (before TIPS) and 6months post TIPS
Secondary outcome [11] 365310 0
Changes in insulin resistance as measured by HOMA-IR
Timepoint [11] 365310 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [12] 365311 0
Changes in Model for End Stage Liver Disease (MELD) score
Timepoint [12] 365311 0
0 (before TIPS), 3 months and 6months post TIPS
Secondary outcome [13] 365312 0
Changes in serum albumin level (g/L)
Timepoint [13] 365312 0
0 (before TIPS), 3 months and 6months post TIPS

Eligibility
Key inclusion criteria
Adult patients > 18 years old with a diagnosis of cirrhosis on biochemical, clinical, histological or radiological criteria
Referred for TIPS for treatment of complications of portal hypertension
Patients who have had a CT abdomen (including the L3 vertebrae) performed 6 weeks prior or within 48 hours of TIPS procedure
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
TIPS for in patients without confirmed cirrhosis

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Prospective observational study assessing changes in muscle mass in this cohort following a defined intervention (TIPS).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12567 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 24946 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 301302 0
Hospital
Name [1] 301302 0
Department of Gastroenterology and Hepatology, Austin Health
Address [1] 301302 0
145 Studley Rd, Heidelberg, Victoria 3084
Country [1] 301302 0
Australia
Primary sponsor type
Hospital
Name
Department of Gastroenterology and Hepatology, Austin Health
Address
145 Studley Rd, Heidelberg, Victoria, 3084
Country
Australia
Secondary sponsor category [1] 300956 0
None
Name [1] 300956 0
Address [1] 300956 0
Country [1] 300956 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302045 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302045 0
145 Studley Rd, Heidelberg, Victoria 3084
Ethics committee country [1] 302045 0
Australia
Date submitted for ethics approval [1] 302045 0
28/11/2018
Approval date [1] 302045 0
11/02/2019
Ethics approval number [1] 302045 0
HREC/49180/Austin-2018

Summary
Brief summary
This study aims to assess changes in body composition following TIPS procedures in decompensated cirrhosis. Patients already referred for TIPS will be recruited from inpatient and outpatient clinics to participate in an observational study with 6 months of follow up. This aims to comprehensively analyse the changes body composition including lean muscle mass, adipose tissue, muscle strength and performance measures and correlate these with biomarkers of immune function, portal hypertension and muscle regulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88942 0
A/Prof Paul Gow
Address 88942 0
Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084
Country 88942 0
Australia
Phone 88942 0
+61 394965353
Fax 88942 0
Email 88942 0
paul.gow@austin.org.au
Contact person for public queries
Name 88943 0
Dr Penelope Hey
Address 88943 0
Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084
Country 88943 0
Australia
Phone 88943 0
+61 394965353
Fax 88943 0
+61394965310
Email 88943 0
penelope.hey@austin.org.au
Contact person for scientific queries
Name 88944 0
Dr Penelope Hey
Address 88944 0
Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084
Country 88944 0
Australia
Phone 88944 0
+61 394965353
Fax 88944 0
Email 88944 0
penelope.hey@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Any publications resulting from this research will be de-identified to protect patient privacy and confidentiality.
What supporting documents are/will be available?
No other documents available
Summary results
No Results