Clinical trial NCT04207424: Embolization of Arterial Gastric Supply in Obesity
Official title: EMbolisation Bariatrique de l'ARcade Gastro-épiploïque Chez Les Patients Obèses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Morbid Obesity
Keywords: Bariatric embolization
Obesity
Metabolic syndrome
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2019-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 7 days post embolization
measure: Number of participants with adverse events
timeFrame: 1 month post embolization
measure: Number of participants with adverse events
timeFrame: 3 months post embolization
measure: Number of participants with adverse events
timeFrame: 6 months post embolization
measure: Number of participants with adverse events
timeFrame: 12 months post embolization
Secondary outcomes:
measure: Change in weight
timeFrame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
measure: Change in abdominal circumference
timeFrame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
measure: Change in thigh circumferences
timeFrame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
measure: Change in Ghrelinemia
timeFrame: Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
measure: Change in Quality of life
timeFrame: Evaluations scheduled at 7 days, 1 month, 3 months, 6 months and 12 months post embolization
measure: Number of upper digestive endoscopies
timeFrame: 12 months after bariatric embolization
Other outcomes:
Locations:
Study officials:
affiliation: Service de Neuroradiologie Interventionnelle, Nouvel Hôpital Civil, Strasbourg
name: Raoul POP, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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