None listed
Conditions
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.
Interventions
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
Sponsors
Christchurch hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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
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
Outcome results
None listed