ANZCTR - Registration

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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

19/01/2023

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

cirrhosis

portal hypertension

sarcopenia

Trans-jugular intrahepatic portosystemic shunt

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Musculoskeletal

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Skeletal muscle index as measured on a single slice CT at the 3rd lumbar vertebrae

Timepoint [1]

CT scan prior to TIPS will be compared to a single slice scan taken at 6 months post TIPS

Secondary outcome [1]

Handgrip strength as measured on the hand dynamometer

Timepoint [1]

Baseline, 3 months and 6 months post TIPS

Secondary outcome [2]

Liver Frailty Index, a measure of muscle strength, endurance and balance

Timepoint [2]

0, 3 months and 6 months post TIPS

Secondary outcome [3]

Short Physical Performance Battery, a test of physical strength and performance

Timepoint [3]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [4]

Changes in hepatic encephalopathy, as measured by the Stroop Test

Timepoint [4]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [5]

Caloric intake (Kcal/d) measured by a study specific instrument

Timepoint [5]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [6]

Assess changes in immune function on a blood sample as measured by quantiferon monitor, a validated immune function assay

Timepoint [6]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [7]

To assess changes in myostatin levels measured on serum samples

Timepoint [7]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [8]

To assess changes in severity of liver disease measured by model for end stage liver disease (MELD) score

Timepoint [8]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [9]

To assess changes in serum IGF-1

Timepoint [9]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [10]

Changes in fasting lipid profile

Timepoint [10]

0 (before TIPS) and 6months post TIPS

Secondary outcome [11]

Changes in insulin resistance as measured by HOMA-IR

Timepoint [11]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [12]

Changes in Model for End Stage Liver Disease (MELD) score

Timepoint [12]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [13]

Changes in serum albumin level (g/L)

Timepoint [13]

0 (before TIPS), 3 months and 6months post TIPS

Secondary outcome [14]

Immune function as measured by quantiferon monitor, a biomarker of immune function in cirrhosis using a blood sample

Timepoint [14]

0 (before TIPS) and 3 and 6 months post TIPS.

Secondary outcome [15]

To assess changes in adipose tissue parameters (subcutaneous fat area, visceral fat area, intermuscular adipose tissue) using the single slice L3 CT scan

Timepoint [15]

At baseline (0 months) and at 6 months post TIPS insertion

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

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

TIPS for in patients without confirmed cirrhosis
Patients unable to perform physical assessments (including handgrip strength) at the time of TIPS procedure due to reduced conscious state or intubation in intensive care.

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

Completed

Date of first participant enrolment

Anticipated

20/02/2019

Actual

1/05/2019

Date of last participant enrolment

Anticipated

1/12/2022

Actual

11/10/2021

Date of last data collection

Anticipated

1/06/2023

Actual

18/04/2022

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Gastroenterology and Hepatology, Austin Health

Address [1]

145 Studley Rd, Heidelberg, Victoria 3084

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

145 Studley Rd, Heidelberg, Victoria 3084

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/11/2018

Approval date [1]

11/02/2019

Ethics approval number [1]

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

A/Prof Paul Gow

Address

Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084

Country

Australia

Phone

+61 394965353

Fax

[email protected]

Contact person for public queries

Name

Penelope Hey

Address

Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084

Country

Australia

Phone

+61 394965353

Fax

+61394965310

[email protected]

Contact person for scientific queries

Name

Penelope Hey

Address

Department of Gastroenterology and Hepatology, Austin Health,
145 Studley Rd, Heidelberg
Victoria, 3084

Country

Australia

Phone

+61 394965353

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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 Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Transjugular intrahepatic portosystemic shunt insertion improves muscle mass but not muscle function or frailty measures.	2023	https://dx.doi.org/10.1097/MEG.0000000000002592

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically