Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Metabolic Syndrome (DJBS-OMS)

The Chinese University of Hong Kong

Status

Enrolling

Conditions

Metabolic Syndrome (MetS)

Obesity

Treatments

Procedure: Implantation of duodenal-jejunal bypass sleeve

Study type

Interventional

Funder types

Other

Identifiers

NCT07675122

CRE-2026.190

Details and patient eligibility

About

This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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