EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Number of participants with adverse events
Study Overview
Brief Summary
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
Detailed Description
Obesity is now an epidemic in the developed and developing world. Medical management is ineffective at population level. Metabolic surgery has been shown to be effective in achieving weight loss and controlling associated conditions. However, surgery is invasive and has associated complications. Furthermore, not every patient is interested in or eligible for surgery.
Bariatric gastric embolization recently emerged as a promising minimally invasive alternative to open bariatric surgery. Data from several initial pilot clinical trials suggests that gastric embolization is safe and can induce weight loss.
Previous studies have concentrated on left gastric artery embolization as the primary target vessel because it supplies the largest portion of the fundus. However, it may be desirable to target a different artery, specifically the left gastroepiploic which also supplies the fundus. The left gastric artery is spared in bariatric surgery because it supplies the residual pouch after the surgery. Embolization of the left gastric artery may result in worse healing in the event of follow-up surgery potentially excluding people should they subsequently want it or become eligible.
This study aims to assess safety and efficacy of bariatric embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles, for patients with morbid obesity.
The target population consists of adult, morbidly obese patients with contraindication for bariatric surgery. Patients included in the study will be followed up for 12 months post bariatric embolization. The primary end point is procedural safety, defined as number and severity of adverse events occurring during the study period. Secondary end points include weight loss, evolution of weight and thigh circumferences, evolution of serum ghrelin levels and evolution of quality of life indexes.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 71 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult patient aged ≥18 and ≤ 71 years old
- •BMI ≥ 40 or BMI ≥ 35 in association with one of the following comorbidities: hypertension, type 2 diabetes, obstructive sleep apnea
- •Relative contraindication to bariatric surgery
- •Able to sign informed consent.
Exclusion Criteria
- •Impossible or unwilling to attend follow-up visits.
- •Weight > 250kg (weight limit of angiography table)
- •Confirmed allergy to intravenous contrast agents.
- •Pregnancy, breast feeding or willingness to conceive during the following year
- •Impossible to maintain dorsal decubitus during intervention
- •Life expectancy < 1 year
- •Current enrollment in another clinical trial
- •Arterial anatomy rendering embolization very difficult or impossible (as evaluated by investigators)
- •Patient under the protection of justice
- •Patient under guardianship or trusteeship
- •Gastro-intestinal
- •Pre-existing chronic abdominal pain
- •History of inflammatory bowel disease
- •History of gastroparesis
- •History of gastric surgery, gastric embolization or radiotherapy
- •History of peptic ulcer
- •Significant risk factors for peptic ulcer, including daily use of non-steroidal anti-inflammatory drugs, active smoking or active infection with Helicobacter pylori
- •Abnormal upper digestive endoscopy
- •Cirrhosis
- •Portal venous hypertension
- •Bilirubin > 2,0 mg/dL
- •Albumin < 2,5 g/L
- •Cardiovascular
- •Known aortic pathology i.e. aneurysm or dissection
- •Severe peripheral arterial disease
- •- Renal failure, Creatinine Clearance < 60ml/min/1,73 m2
- •Hematologic/Immunologic/Oncologic/Infectious
- •Acute or chronic infection
- •Active cancer
- •Auto-immune disease requiring immunosuppression
- •Neutrophil count < 1,5 x 10 ^ 9/L
- •Platelet count < 100 x 10 ^ 9/L
- •Contraindication to contrast medium Visipaque solution for injection
- •Hypersensitivity to the active substance (Iodixanol) or to any of the excipients
- •History of immediate major or delayed skin reaction to the injection of the product
- •Decompensated heart failure
- •Thyrotoxicosis
- •Contraindication to the use of the embogold microsphere
Arms & Interventions
Embolization
Patients undergoing embolization of the gastro-epiploic arcade
Intervention: Emblization of the gastro-epiploic arcade (Procedure)
Outcomes
Primary Outcomes
Number of participants with adverse events
Time Frame: 12 months post embolization
Number of participants with adverse events
Time Frame: 7 days post embolization
Number of participants with adverse events
Time Frame: 1 month post embolization
Number of participants with adverse events
Time Frame: 3 months post embolization
Number of participants with adverse events
Time Frame: 6 months post embolization
Secondary Outcomes
- Change in weight(Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization)
- Change in abdominal circumference(Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization)
- Change in thigh circumferences(Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization)
- Change in Quality of life(Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization)
- Change in Ghrelinemia(Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization)
- Number of upper digestive endoscopies(12 months after bariatric embolization)