Morbid Obesity
Conditions
Keywords
Bariatric embolization, Obesity, Metabolic syndrome
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.
Interventions
PROCEDUREEmblization of the gastro-epiploic arcade
Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles
Sponsors
IHU Strasbourg
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with adverse events | 7 days post embolization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization | Weight loss expressed in percentage of total weight loss (%TWL) |
| Change in abdominal circumference | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | Measurement of abdominal circumference in centimetres |
| Change in thigh circumferences | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | Measurement of thigh circumferences in centimetres |
| Change in Ghrelinemia | Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization | Measurement of serum ghrelin concentration |
| Change in Quality of life | Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization | 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). |
| Number of upper digestive endoscopies | 12 months after bariatric embolization | Count of upper digestive endoscopies performed per patient during the study period |
Contacts
PRINCIPAL_INVESTIGATORRaoul POP, MD, PhD
Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg
Outcome results
None listed