Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000066189p
Ethics application status
Not yet submitted
Date submitted
17/12/2018
Date registered
17/01/2019
Date last updated
17/01/2019
Date data sharing statement initially provided
17/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Endoscopic Sleeve Gastroplasty for fatty liver disease and metabolic syndrome
Scientific title
Investigating the effect of Endoscopic Sleeve Gastroplasty (ESG) on Non-alcoholic Fatty Liver Disease (NAFLD) and the metabolic syndrome in obese participants
Secondary ID [1] 296893 0
nil
Universal Trial Number (UTN)
U1111-1225-6797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Alcoholic fatty Liver Disease 310839 0
Obesity 310840 0
Metabolic syndrome 310841 0
Condition category
Condition code
Oral and Gastrointestinal 309512 309512 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 309513 309513 0 0
Obesity
Metabolic and Endocrine 309514 309514 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 313169 0
Treatment: Surgery
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308468 0
Liver biopsy assessment of change in Non Alcoholic Fatty Liver Disease histologic score (NAFLD Activity Score; NAS).
Timepoint [1] 308468 0
1 year post ESG Liver Biopsy
Secondary outcome [1] 355041 0
Change in insulin resistance with blood test, 1 year post ESG
Timepoint [1] 355041 0
1 year post ESG
Secondary outcome [2] 355042 0
Weight loss (total body weight change measured on electronic scales in Kg) at 1 year post ESG
Timepoint [2] 355042 0
1 year post ESG
Secondary outcome [3] 355043 0
Change in blood pressure with bench top spygmomanometer 1 year post ESG
Timepoint [3] 355043 0
1 year post ESG
Secondary outcome [4] 355044 0
Change in liver fat on fibroscan at 1 year post ESG
Timepoint [4] 355044 0
1 year post ESG, fibroscan assessment of liver fat with computerised attenuation parameter (CAP)
Secondary outcome [5] 355045 0
Change in lipid profile at 1 year post ESG with blood test.
Timepoint [5] 355045 0
1 year post ESG blood test

Eligibility
Key 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
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Pilot trial to look at efficacy in 10 patients

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/05/2019
Actual
Date of last participant enrolment
Anticipated
18/11/2019
Actual
Date of last data collection
Anticipated
22/11/2021
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 21131 0
New Zealand
State/province [1] 21131 0
Auckland

Funding & Sponsors
Funding source category [1] 301464 0
Hospital
Name [1] 301464 0
Auckland City Hospital Trust
Country [1] 301464 0
New Zealand
Primary sponsor type
Hospital
Name
New Zealand Liver Transplant Unit
Address
Auckland City Hospital
Level 15
Park Road, Grafton
Auckland
1148
Country
New Zealand
Secondary sponsor category [1] 301155 0
None
Name [1] 301155 0
Address [1] 301155 0
Country [1] 301155 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302199 0
Health and Disability Ethics Committe
Ethics committee address [1] 302199 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302199 0
New Zealand
Date submitted for ethics approval [1] 302199 0
11/02/2019
Approval date [1] 302199 0
Ethics approval number [1] 302199 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89450 0
Dr David Orr
Address 89450 0
New Zealand Liver Transplant Unit
Auckland City Hospital,
Park Road
Grafton
Auckland 1148
Country 89450 0
New Zealand
Phone 89450 0
+6493074949
Fax 89450 0
Email 89450 0
[email protected]
Contact person for public queries
Name 89451 0
Dr David Orr
Address 89451 0
New Zealand Liver Transplant Unit
Auckland City Hospital,
Park Road
Grafton
Auckland 1148
Country 89451 0
New Zealand
Phone 89451 0
+6493074949
Fax 89451 0
Email 89451 0
[email protected]
Contact person for scientific queries
Name 89452 0
Dr David Orr
Address 89452 0
New Zealand Liver Transplant Unit
Auckland City Hospital,
Park Road
Grafton
Auckland 1148
Country 89452 0
New Zealand
Phone 89452 0
+6493074949
Fax 89452 0
Email 89452 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.