Embargo: Embolization of Arterial Gastric Supply in Obesity

Sponsor

IHU Strasbourg (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04207424

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Emblization of the gastro-epiploic arcade	N/A

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.

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

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Embolization Patients undergoing embolization of the gastro-epiploic arcade	Procedure: Emblization of the gastro-epiploic arcade Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles

Arm

Intervention/Treatment

Experimental: Embolization

Patients undergoing embolization of the gastro-epiploic arcade

Procedure: Emblization of the gastro-epiploic arcade

Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 71 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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