Non-invasive diagnosis and monitoring of non-alcoholic fatty liver disease in bariatric surgical patients

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000875505
• Date of registration: 21/08/2015
• Prospective Registration: No
• Primary sponsor: Centre for Obesity Research and Education, Monash University
• Public title: Non-invasive diagnosis and monitoring of non-alcoholic fatty liver disease in bariatric surgical patients
• Scientific title: Efficacy of non-invasive tests in diagnosing and monitoring NAFLD in adult bariatric surgical patients
• Date of first enrolment: 29/06/2015
• Target sample size: 190
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12615000875505.aspx
• Study type: Interventional
• Study design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Blinded (masking used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Geraldine Ooi

• Name: Dr Geraldine Ooi

Key inclusion & exclusion criteria

Inclusion criteria: Patients >17 years undergoing bariatric surgery and any of:
- AST or ALT > 0.5 upper limit normal
- GGT > upper limit normal
- Abnormal transient elastography
- Abnormal ultrasound suggesting NAFLD

Exclusion criteria: Other cause of liver disease
Past or current excessive ETOH


Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Obesity;Non-alcoholic fatty liver disease ;Bariatric surgery ;
Obesity
Non-alcoholic fatty liver disease

Bariatric surgery

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

Surgery - Other surgery

Diet and Nutrition - Obesity

Intervention(s)

MAGNETIC RESONANCE SPECTROSCOPY (MRS)
This is an MRI scan, where the patient lies flat on a platform which is moved through the MRI tunnel. The procedure takes approximately 30 minutes and is carried out by the radiographer. The test is performed at baseline, and follow-up MRS is performed at 1 year after bariatric surgery. Patients will be seen in clinic prior to their scans to arrange a suitable time. Attendance will be checked by the study investigator and rescheduled if required.

TRANSIENT ELASTOGRAPHY/FIBROSCAN
This test looks at liver stiffness. Patients are scheduled for 3 scans during their year long follow-up (baseline, 3 and 12 months after bariatric surgery). The scan is performed in an outpatient clinic, with a probe on the right upper abdomen, similar to an ultrasound. The procedure takes approximately 10 minutes. It is not painful and there are no risks. The procedure is performed by trained Gastroenterologists. Attendance will be checked by the study investigator and rescheduled if required.

SERUM BIOMARKERS
Blood tests are taken from the patient at 0, 1, 3 and 12 months after bariatric surgery at their scheduled outpatient appointments. Approximately 20-30ml of blood will be taken at each time point. Tests of interest include routine blood tests, as well as the novel biomarker TNFSF14 (LIGHT) and other circulating cytokines.

BARIATRIC SURGERY
Surgery will occur as planned by their treating team.

Primary Outcome(s)

Efficacy of transient elastography in measuring NAFLD in the bariatric cohort by comparison with liver biopsy[Baseline (around time of bariatric surgery - comparing to intraoperative liver biopsy), 3 months and 1 year (comparing to percutaneous liver biopsy)]

Efficacy of MR spectroscopy in measuring NAFLD in the bariatric cohort by comparison to liver biopsy[Baseline (comparing to intraoperative liver biopsy) and 1 year (comparing to percutaneous liver biopsy)]

Efficacy of serum biomarkers in measuring NAFLD in the bariatric cohort by comparison to liver biopsy[Baseline (comparing to intraoperative liver biopsy), 1 month, 3 months and 1 year (comparing to percutaneous liver biopsy)]

Secondary Outcome(s)

Correlation of mRNA profile of adipose tissue with liver biopsy in patients with NAFLD. [Baseline]

Change in NAFLD with surgically induced weight loss as measured by liver biopsy[Baseline and 1 year]

Secondary ID(s)

Nil

Source(s) of Monetary Support

The Alfred Research Trust

Centre for Obesity Research and Education, Monash University

Secondary Sponsor(s)

Department of Gastroenterology and Department of Upper Gastrointestinal Surgery, The Alfred Hospital

Ethics review

Status: Approved
Approval date:
Contact:

Monash University HREC

Status: Approved
Approval date:
Contact:

The Alfred HREC