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Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients | Clinical Trials | Clareo Health

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Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

NCT05710263•Centre Hospitalier Universitaire, Amiens

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+6 more criteria

Key Dates

Start Date

January 10, 2023

Primary Completion Date

February 13, 2025

Completion Date

February 13, 2025

Last Updated

February 17, 2025

Conditions

Sleeve GastrectomyMorbid ObesityBariatric Surgery

Interventions

bariatric embolization

PROCEDURE

Adherence to an Exercise Program and Pre- and Post-Changes After Bariatric Surgery

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

Inclusion Criteria

Exclusion Criteria

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