Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

Morbid Obesity Clinical Trial

— EMBOSLEEVE  

Official title:

Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710263
• Other study ID #: PI2019_843_0043
• Status: Recruiting
• Phase: N/A
• Start date: January 10, 2023
• Est. completion date: January 2028

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Cyril Chivot, MD
• Phone: 03 22 08 75 38
• Email: chivot.cyril[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In patients with severe obesity, bariatric surgery provides consistent and long-term weight loss. BMI ≥50kg / m2 is an independent factor of increased morbidity / mortality in bariatric surgery compared with patients weighing less than 50 kg / m2 (1.2% and 0.8%) mainly due to technical difficulties. Preoperative weight loss reduces this morbidity / mortality. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of the appetite inducing hormone ghrelin, and result in weight loss. The purpose of this study was to evaluate the safety and effectiveness of the association bariatric embolization before sleeve gastrectomy in super obese patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing, able and mentally competent to provide written informed consent.

• Body mass index (BMI) >50kg/m².

• 3 risk factors (De Maria et al) among: hypertension, male gender, age>45, risk of pulmonary embolism

• Vascular anatomy (including celiac, hepatic, and gastric arteries) that in the opinion of the interventional radiologist amenable to Bariatric Embolization, as assessed on 3D CT angiography.

• Adequate hematological, hepatic and renal function as follows:

Hematological Neutrophils > 1.5 x 109/L Platelets > 100 x 109/L INR <1.5 Hepatic Bilirubin = 2.0 mg/dL Albumin = 2.5 g/L Renal Estimated GFR > 60ml/min.1.73m2

• Aged 18 years or older.

• Patient who is going to be operated by sleeve gastrectomy

Exclusion Criteria:

• Prior history of gastric pancreatic, hepatic, and/or splenic surgery

• Prior radiation to the upper abdomen

• Prior embolization to the stomach, spleen or liver

• Portal venous hypertension

• Prior or current history of peptic ulcer disease

• Significant risk factors for peptic ulcer disease including daily NSAID use and smoking.

• Active H. Pylori infection

• Weight greater than 240 kg

• Known aortic pathology such as aneurysm or dissection renal insufficiency as evidenced by an estimated glomerular filtration rate of < 60 milliliters per minute

• Major comorbidity such as cancer, significant cardiovascular disease, diabetes, or peripheral arterial disease.

Pregnancy

• ASA Class 4 or 5 (very high risk surgical candidates: class 4= incapacitating disease that is a constant threat to life) at the time of screening for enrollment into the study will be excluded from participation. This exclusion criterion exists because of the possibility that surgical intervention will be needed if the study intervention subsequently leads to severe adverse effects.

• History of Inflammatory Bowel Disease

• Cirrhosis

• Known history of allergy to iodinated contrast media

• Contraindications to use Embosphere (ex:known allergy to gelatin ..)

Related Conditions & MeSH terms

• Bariatric Surgery
• Morbid Obesity
• Obesity, Morbid
• Sleeve Gastrectomy

Intervention

Procedure:
• bariatric embolization
bariatric or left gastric artery embolization

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NUmber of Adverse Events		12 months
Secondary	Weight Loss	Unit of Measure: Percentage of excess weight loss	12 months