Metabolic Effects of Bariatric Arterial Embolization vs Bariatric Surgery

Korábbi kezelés

• Prior bariatric surgery of any kind.
• Prior complex abdominal surgery including splenectomy, upper GI, anti-reflux surgery and trauma.
• Abdominal, thoracic, pelvic and/or obstetric-gynaecologic surgery within 3 months or at the discretion of the surgery.
• Cardiovascular conditions including uncompensated congestive heart failure, dysrhythmia, history of stroke, or uncontrolled hypertension (defined as medically treated with the mean of 3 separate measurements systolic blood pressure (SBP)> 180 mmHg or diastolic blood pressure (DBP) >110mmHg). Patients with coronary artery disease (CAD) that have been successfully treated with coronary artery by-pass graft (CABG) or percutaneous coronary intervention (PCI) or are 1 year after implantation of drug eluting stent and have no evidence of active ischemia are eligible.
• Psychiatric disorders including dementia, active psychosis, severe depression requiring >2 medications, history of suicide attempts, alcohol or drugs abuse with previous 12months.
• Use of investigational therapy or participation in any other clinical trial within 12 weeks prior to signing the informed consent form.

Más betegség

• Known history of chronic liver disease (except for NAFLD/NASH), hepatitis, positive serologic test result for hepatitis B surface antigen and/or hepatitis C antibody, alpha-1-antitrypsin deficiency.
• Gastrointestinal disorders including a known history of celiac disease and/or other malabsorptive disorders or inflammatory bowel disease (Chron's disease or ulcerative colitis).
• Malignancy within 5 years (except squamous cell and basal cell cancer of skin).
• Any medical condition requiring anticoagulation therapy that cannot be temporarily discontinued for surgical or embolic approach.
• Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study.
• Severe pulmonary disease.
• History of allergy to iodinated contrast media

Laborértékek

• Anaemia defined as haemoglobin less than 9 in females and 10 in males.

Egyéb

• Pregnancy.
• American Society of Anesthesiologists (ASA) physical status class IV or higher.

• criteria:
  • Is the candidate for general anesthesia.
  • Body Mass Index (BMI) between 33 and 43 Kg/m2
  • Patients have a biochemical evidence of Type 2 Diabetes Mellitus (DMT2) confirmed by American Diabetes Association (ADA) criteria:
  • 3.1) treated - HbA1c 7,1%; 3.2) If untreated- fasting 2-hour plasma glucose level of 200 mg/dL during an oral glucose tolerance test and a HbA1c of 7,1%.
  • Willing, able, and mentally competent to provide written informed consent.
  • Able o understand the options and to comply with the requirements of each program.
  • Have a negative urine pregnancy test at screening and baseline visits (prior surgery and Embolization) for women of childbearing potential.
  • Female patients must agree to use reliable method of contraception for 2 years.