None listed
Conditions
Brief summary
This is a prospective cohort study for patients undergoing bariatric surgery who have risk factors for NAFLD, to investigate the impact of surgical weight loss on the liver. Patients who are already scheduled for bariatric surgery who fit criteria for likely NAFLD will be recruited from The Alfred Hospital, to undergo an intraoperative liver and adipose tissue biopsy. Patients with significant liver disease on initial biopsy (NAFLD activity score (NAS) greater than 4 or fibrosis score greater than F1) will be offered a follow-up liver biopsy at 12-months post-operatively. Liver tissues will be investigated for markers that may indicate disease prognosis and underlying pathophysiology, particularly immune cell markers.
Interventions
Bariatric Surgery:
- Laparoscopic adjustable gastric banding [approximately 1 hour]
- sleeve gastrectomy (laparoscopic or open) [approximately 1-2 hours]
- gastric bypass (laparoscopic or open) [approximately 2-3 hours]
- BPD [approximately 2-3 hours]
Choice of bariatric surgery will be at patient and clinician discretion.
Liver biopsy and adipose tissue biopsy will be taken during the operation.
- Liver biopsy may sometimes be taken by the surgeon if there is obvious liver disease macroscop
Bariatric Surgery: - Laparoscopic adjustable gastric banding [approximately 1 hour] - sleeve gastrectomy (laparoscopic or open) [approximately 1-2 hours] - gastric bypass (laparoscopic or open) [approximately 2-3 hours] - BPD [approximately 2-3 hours] Choice of bariatric surgery will be at patient and clinician discretion. Liver biopsy and adipose tissue biopsy will be taken during the operation. - Liver biopsy may sometimes be taken by the surgeon if there is obvious liver disease macroscopically, or pre-operative suspicion. It is not routine for all patients. - Adipose tissue biopsy is not part of routine clinical care and is taken for research purposes only.
Sponsors
Centre for Obesity Research and Education, Monash University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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
Outcome results
None listed