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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05710263
Other study ID # PI2019_843_0043
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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 ..)

Study Design


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
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