Embolization of Arterial Gastric Supply in Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Emblization of the gastro-epiploic arcade


Participation Criteria
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Eligibility Criteria
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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: General 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 Hepatic 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 - 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Embolization<br>Patients undergoing embolization of the gastro-epiploic arcade | Procedure: Emblization of the gastro-epiploic arcade<br>* Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | 7 days post embolization | 
| Number of participants with adverse events |  | 1 month post embolization | 
| Number of participants with adverse events |  | 3 months post embolization | 
| Number of participants with adverse events |  | 6 months post embolization | 
| Number of participants with adverse events |  | 12 months post embolization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight | Weight loss expressed in percentage of total weight loss (%TWL) | Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization | 
| Change in abdominal circumference | Measurement of abdominal circumference in centimetres | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | 
| Change in thigh circumferences | Measurement of thigh circumferences in centimetres | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | 
| Change in Ghrelinemia | Measurement of serum ghrelin concentration | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | 
| Change in Quality of life | Quality of Life is scored using Moorehead-Ardelt II Quality of life questionnaire. The questionnaire involves 6 questions scored from -0,5 to +0,5. The mean of the 6 answers leads to a sum between -3 (very poor quality of life) to +3 (very good quality of life). | Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization | 
| Number of upper digestive endoscopies | Count of upper digestive endoscopies performed per patient during the study period | 12 months after bariatric embolization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Bariatric embolization, Metabolic syndrome