Embolization of Arterial Gastric Supply in Obesity

Morbid Obesity Clinical Trial

— Embargo  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04207424
• Other study ID #: 19-005
• Status: Withdrawn
• Phase: N/A
• Start date: April 2021
• Est. completion date: May 2025

Study information

• Verified date: March 2022
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2025
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

References & Publications (24)

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De Wispelaere JF, De Ronde T, Trigaux JP, de Cannière L, De Geeter T. Duodenal ulcer hemorrhage treated by embolization: results in 28 patients. Acta Gastroenterol Belg. 2002 Jan-Mar;65(1):6-11. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events		7 days post embolization
Primary	Number of participants with adverse events		1 month post embolization
Primary	Number of participants with adverse events		3 months post embolization
Primary	Number of participants with adverse events		6 months post embolization
Primary	Number of participants with adverse events		12 months post embolization
Secondary	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
Secondary	Change in abdominal circumference	Measurement of abdominal circumference in centimetres	Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Secondary	Change in thigh circumferences	Measurement of thigh circumferences in centimetres	Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Secondary	Change in Ghrelinemia	Measurement of serum ghrelin concentration	Evaluations scheduled at 1 month, 3 months, 6 months and 12 months post embolization
Secondary	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
Secondary	Number of upper digestive endoscopies	Count of upper digestive endoscopies performed per patient during the study period	12 months after bariatric embolization

External Links

•   Centers for Disease Control and Prevention. Adult obesity facts.