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Endoscopic Sleeve Gastroplasty for fatty liver disease and metabolic syndrome

Investigating the effect of Endoscopic Sleeve Gastroplasty (ESG) on Non-alcoholic Fatty Liver Disease (NAFLD) and the metabolic syndrome in obese participants

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000066189
Enrollment
10
Registered
2019-01-17
Start date
2019-05-20
Completion date
2019-11-18
Last updated
2019-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim of the study is to initiate weight loss with endoscopic sleeve gastroplasty (ESG). The study hopes to show that ESG results in significant weight loss and improves fatty liver disease, diabetes, blood pressure and cholesterol. Endoscopic Sleeve Gastroplasty is an incisionless procedure that uses an endoscope which can suture the stomach. The stomach volume is reduced by 50-70% under general anaesthetic. This is accomplished by a series of endoscopically placed sutures extending from the bottom 1/3 of the stomach to the upper stomach creating a “sleeve”. Patients aged 20 to 65 years who are overweight (BMI 30-45Kg/m2), have fatty liver disease on liver biopsy and elevated insulin-glucose ratio, or diabetes, or hypertension or elevated cholesterol will be eligible for the trial. You will be followed up over the next 2 years, with a repeat liver biopsy 1 year after the procedure to assess if the fatty liver disease has resolved or improved. Your insulin resistance or diabetes, blood pressure and cholesterol will also be assessed to determine if the intervention improves these metabolic risk factors.

Interventions

Patients with Non-alcoholic fatty liver disease, who are obese (BMI 30- 45Kg/m2) will be assessed for the intervention. This will include a liver biopsy to assess the degree of fatty liver disease. If included in the trial, the intervention is an Endoscopic Sleeve gastroplasty (ESG) which will be undertaken under general anesthetic in patients with non-alcoholic fatty liver disease and metabolic risk factors. The procedure will be performed at Auckland City Hospital, the interventional endoscopi

Patients with Non-alcoholic fatty liver disease, who are obese (BMI 30- 45Kg/m2) will be assessed for the intervention. This will include a liver biopsy to assess the degree of fatty liver disease. If included in the trial, the intervention is an Endoscopic Sleeve gastroplasty (ESG) which will be undertaken under general anesthetic in patients with non-alcoholic fatty liver disease and metabolic risk factors. The procedure will be performed at Auckland City Hospital, the interventional endoscopist is Dr David Orr, who has been undertaking interventional endoscopy at Auckland Hospital for >12 years and at King's College Hospital, London before this time. Patients will be assessed and followed up by a specialist team of bariatric nurse, dietician and psychologist. The procedure duration is 1.5 hours. A gastroscope is passed into the stomach to confirm that there are no contra-indications to proceeding with the ESG. The stomach is then marked to show the orientation of the stomach for the endoscopist during the procedure. The Overstitch device is then attached to the endoscope and placed into the stomach. Approximately 8 stitches are placed in a double layer pattern to reduce the diameter and shorten the stomach. You will remain in hospital for one night post procedure. After discharge, you will be seen in outpatient clinic at week 1, then monthly for 3 months, then every 3 months for up to 2 years at Auckland Hospital. 1 year after the procedure, you will undergo a repeat liver biopsy to assess if the ESG has resulted in improvement and/or resolution of your non-alcoholic fatty liver disease. As part of standard of care, you will continue follow up in the hepatology clinic every 3 months after the procedure.

Sponsors

New Zealand Liver Transplant Unit
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Liver biopsy with NAFLD/NASH (NAS score greater than or equal to 4), (or historic biopsy within 6-months) AND 2. BMI 30- 45Kg/m2. AND at least one additional metabolic risk factor: (HT, Type II diabetes or dyslipidaemia). AND 3. Age 20- 65

Exclusion criteria

Patients with cirrhosis of the liver and/or portal hypertension, Antiplatelet therapy (excluding low dose aspirin), Severe cardiac or respiratory disease, Previous gastric surgery, Hiatus hernia >3cm Inflammatory bowel disease, Pregnancy, or breast feeding. No other liver disease (excluded viral hepatitis, AIH, HFe, alpha-1 AT deficiency), Medications known to cause steatohepatitis. Alcohol consumption: >21U/ week male, >14U/week female Unable to follow dietary guidelines.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026