EMBOSLEEVE: Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Recruiting

CT.gov ID

NCT05710263

Collaborator

(none)

Enrollment

Location

59.7

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sleeve Gastrectomy Morbid Obesity Bariatric Surgery	Procedure: bariatric embolization	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

Actual Study Start Date :

Jan 10, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 1, 2028

Outcome Measures

Primary Outcome Measures

NUmber of Adverse Events [12 months]

Secondary Outcome Measures

Weight Loss [12 months]
Unit of Measure: Percentage of excess weight loss

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 ..)