Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

NCT ID: NCT05710263

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2025-02-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Interventions

bariatric embolization

bariatric or left gastric artery embolization

Intervention Type: PROCEDURE

Eligibility Criteria

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 ..)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

PI2019_843_0043

Identifier Type: -

Identifier Source: org_study_id