Overview
This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
Description
This is a prospective, single-arm study enrolling individuals with obesity. Participants will receive 3 months implantation of duodenal-jejunal bypass sleeve (DJBS). They will be followed for another 9 months after removal of DJBS to assess the outcomes.
Eligibility
Inclusion Criteria:
- Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome
Exclusion Criteria:
- Patients who have lost more than 5 kg of weight in the past three months
- Patients who have used glucagon-like peptide-1 receptor agonists (GLP-1RAs) in the past three months
- Patients who are currently taking weight loss drugs such as orlistat
- Those who have taken antiplatelet drugs or anticoagulant drugs such as aspirin in the past month
- iron deficiency or iron deficiency anemia
- Gastrointestinal malformations, such as patients with gastrointestinal atresia or other patients who will cause gastrointestinal implantation failure
- Those with a history of cholecystitis and liver abscess
- There is a known infection, and the type of disease and the severity of the infection are not suitable for use by clinicians
- coagulation dysfunction;
- Severe liver and kidney dysfunction, AST /ALT \> 2.5 times, total bilirubin \> 35 μmol/L, blood creatinine concentration greater than 180 μmol/L
- Patients with ASA IV \& V
- Drug or alcohol abuse addiction or suffering from uncontrollable mental illness
- Duodenal bulb ulcer, gastric ulcer or previous and existing pancreatitis
- Coronary heart disease, angina, cardiac function grade III or above, or pulmonary dysfunction
- Patients who have undergone ERCP before
- Patients with potential bleeding or telangiectasia in the stomach, esophagus, small intestine and other parts
- Have a history of systemic lupus erythematosus, scleroderma
- Those who have contraindications to endoscopy (judged by clinicians)
- Pregnant women or those who are preparing to become pregnant
- Those who are allergic to nickel-titanium
- Any other situation that the clinician deems unsuitable for participation in this product
