Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

NCT05710263 | Withdrawn

• 1 other identifier: PI2019_843_0043
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sleeve Gastrectomy; Morbid Obesity; Bariatric Surgery

Keywords

bariatric embolization; sleeve gastrectomy; super obese; left gastric artery; Morbid Obesity; bariatric surgery

Outcome Measures

Primary Outcomes (1)

• NUmber of Adverse Events

  12 months

Secondary Outcomes (1)

• Weight Loss

  12 months

Interventions

bariatric embolization PROCEDURE

bariatric or left gastric artery embolization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing, able and mentally competent to provide written informed consent.
• Body mass index (BMI) \>50kg/m².
• 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

You may not qualify if:

• 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
• History of Inflammatory Bowel Disease
• Cirrhosis
• Known history of allergy to iodinated contrast media
• Contraindications to use Embosphere (ex:known allergy to gelatin ..)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: January 10, 2023
• Primary Completion: February 13, 2025
• Study Completion: February 13, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share