Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001453370
Ethics application status
Approved
Date submitted
8/06/2015
Date registered
13/10/2017
Date last updated
13/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Left Gastric Artery Embolization for New Zealand patients with morbid obesity who are not fit for bariatric surgery
Scientific title
Left Gastric Artery Embolization for New Zealand patients with morbid obesity who are not fit for bariatric surgery, specifically weight loss and reduction of obesity related co-morbities
Secondary ID [1] 292494 0
none
Universal Trial Number (UTN)
U1111 - 1169 - 0549
Trial acronym
FAST- LEAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 295273 0
co-morbidities relating to obesity 295274 0
Condition category
Condition code
Diet and Nutrition 295524 295524 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Percutaneous embolization of the left gastric artery performed under conscious sedation by Dr martin Krauss, an Interventional Radiologist. The common femoral artery is accessed using seldinger technique and guidewires and catheters placed to reach the target left gastric artery. Embozene particles are used to embolize. The procedure takes 45-90 minutes and performed as a day case
Intervention code [1] 298673 0
Treatment: Devices
Intervention code [2] 298803 0
Lifestyle
Intervention code [3] 298804 0
Treatment: Surgery
Comparator / control treatment
Lifestyle changes, diet and exercise is the treatment. Dietary intake and exercise will be recorded. The patients are followed up in research clinics at the same timepoints as the embolization group. patients will be asked to keep food diaries and follow the green prescription exercise plan as per the New Zealand Ministry of Health guidelines
Patients that do not qualify for bariatric surgery in normal practice are routinely referred back to their GPs and have no regular follow up, intervention or surveillance
Control group
Active

Outcomes
Primary outcome [1] 295263 0
to evaluate the extent of weight loss from percutaneous embolization of the left gastric artery in morbidly obese patients who are unfit for bariatric surgery. Weight loss as assessed by digital scales
Timepoint [1] 295263 0
They are followed up until 60 months post embolization
Secondary outcome [1] 338123 0
Evaluate the safety of percutaneous embolization
Timepoint [1] 338123 0
clinical assessments including a physical examination including adverse events such as haematoma at groin puncture site, ongoing pain as assessed at 3, 6, 12, 24 and 60 months
Pain is assessed using a 10 point VAS score
Secondary outcome [2] 338564 0
Evaluate change of blood pressure after embolisation
Timepoint [2] 338564 0
collect blood pressure measurements from patients from procedure day and 3, 6, 12, 24 and 60 months
Secondary outcome [3] 339684 0
Evaluate change of diabetes medication (if applicable) after embolisation
Timepoint [3] 339684 0
collect medication details from patients or by review of medical records ,on procedure day and at 3, 6, 12, 24 and 60 months

Eligibility
Key inclusion criteria
age >18 years -80 years, willing and able to make an informed decision and sign consent
BMI >40
significant risk factors precluding bariatric surgery
vascular anatomy (as per CTA) amenable to bariatric embolization
normal laboratory parameters ie platelets >100, INR<1.5, bilirubin <2.0
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
previous gastric, pancreatic, hepatic and or splenic surgery
prior radiation to upper abdomen
prior embolization to the stomach spleen or liver
portal venous hypertension
peptic ulcer disease
hiatal hernia
active H pylori infection
weight greater than 250kg
eGFR <60ml/min
complicated arterial anatomical variants including left gastric artery
pregnancy
ASA class 4-5
contrast allergy
significant psychiatric disorders

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be identified by the the bariatric surgeons. the patients who are assessed as being too great a surgical risk to undergo bariatric surgery will be recuited. These patients will be randomised to either a control group or a treatment group. Allocation is not concealed The control group will receive standard of care diet and exercise. The treatment group will receive embolization of the left gastric artery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization. Coin toss
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2017
Actual
Date of last participant enrolment
Anticipated
30/08/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment outside Australia
Country [1] 6961 0
New Zealand
State/province [1] 6961 0
Canterbury

Funding & Sponsors
Funding source category [1] 291432 0
Hospital
Name [1] 291432 0
Christchurch hospital
Country [1] 291432 0
New Zealand
Primary sponsor type
Hospital
Name
Christchurch hospital
Address
2 Riccarton Avenue
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 290108 0
None
Name [1] 290108 0
none
Address [1] 290108 0
none
Country [1] 290108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292983 0
upper south ethics committee
Ethics committee address [1] 292983 0
Ministry of Health
Ethics Department
reception - ground floor
20 Aitken Street
Wellington 8000
Ethics committee country [1] 292983 0
New Zealand
Date submitted for ethics approval [1] 292983 0
Approval date [1] 292983 0
05/08/2015
Ethics approval number [1] 292983 0

Summary
Brief summary
Morbid obesity is a signifiacnt health problem in New Zealand, especialy among the Maori and Pacific Island population. The most effective way to treat this condition is bariatric surgery but not all patients are eligible if their obesity related co-morbidities deem surgery as too risky.
Percutaneous embolization is minimally invasive and performed as a day case under local anaesthetic and sedation. The study aims to prove this new embolization procedure to be a safe effective treatment for obese people that have no other options available to them.
Trial website
none
Trial related presentations / publications
none
Public notes
none

Contacts
Principal investigator
Name 57902 0
Dr Martin Krauss
Address 57902 0
Interventional Radiologist
Radiology Department
Christchurch Hospital 8014
2 Riccarton Avenue
Christchurch
Country 57902 0
New Zealand
Phone 57902 0
+64 3 3640640
Fax 57902 0
+ 64 3 364198
Email 57902 0
[email protected]
Contact person for public queries
Name 57903 0
Martin Krauss
Address 57903 0
Interventional Radiologist
Radiology Department
Christchurch Hospital
2 Riccarton Avenue 8014
Christchurch
Country 57903 0
New Zealand
Phone 57903 0
+64 3 3640640
Fax 57903 0
Email 57903 0
[email protected]
Contact person for scientific queries
Name 57904 0
Martin Krauss
Address 57904 0
Interventional Radiologist
Radiology Department
Christchurch Hospital
2 Riccarton Avenue 8014
Christchurch
Country 57904 0
New Zealand
Phone 57904 0
+ 64 3 3640640
Fax 57904 0
Email 57904 0
[email protected]

No information has been provided regarding IPD availability


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.