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Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients (EMBOSLEEVE)

Primary Purpose

Sleeve Gastrectomy, Morbid Obesity, Bariatric Surgery

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
bariatric embolization
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for Sleeve Gastrectomy focused on measuring bariatric embolization, sleeve gastrectomy, super obese, left gastric artery, Morbid Obesity, bariatric surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 ..)

Sites / Locations

  • CHU Amiens-PicardieRecruiting

Outcomes

Primary Outcome Measures

NUmber of Adverse Events

Secondary Outcome Measures

Weight Loss
Unit of Measure: Percentage of excess weight loss

Full Information

First Posted
January 24, 2023
Last Updated
January 24, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT05710263
Brief Title
Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients
Acronym
EMBOSLEEVE
Official Title
Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2023 (Actual)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleeve Gastrectomy, Morbid Obesity, Bariatric Surgery
Keywords
bariatric embolization, sleeve gastrectomy, super obese, left gastric artery, Morbid Obesity, bariatric surgery

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
bariatric embolization
Intervention Description
bariatric or left gastric artery embolization
Primary Outcome Measure Information:
Title
NUmber of Adverse Events
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight Loss
Description
Unit of Measure: Percentage of excess weight loss
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ..)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cyril Chivot, MD
Phone
03 22 08 75 38
Email
chivot.cyril@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
ZIP/Postal Code
80054
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cyril CHIVOT, Dr
Phone
(33)322087538
Email
chivot.cyril@chu-amiens.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Bariatric Embolization Before Sleeve Gastrectomy for Super Obese Patients

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