RecruitingNot ApplicableNCT07675122
Duodenal-jejunal Bypass Sleeve (DJBS) for Obesity and Metabolic Syndrome
Endoscopic Duodenal-jejunal Bypass Sleeve for Treatment of Obesity and Metabolic Syndrome - a Multicenter Pilot Study
Sponsor
Chinese University of Hong Kong
Enrollment
20 participants
Start Date
Sep 1, 2026
Study Type
INTERVENTIONAL
Conditions
Summary
This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
Eligibility
Min Age: 18 YearsMax Age: 65 Years
Inclusion Criteria1
- Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome
Exclusion Criteria21
- 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
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Interventions
PROCEDUREImplantation of duodenal-jejunal bypass sleeve
The duodenal-jejunal bypass sleeve (DJBS) is a 60 cm thin, flexible tube. It is implanted into the duodenum using an endoscopy procedure and is kept in place for 3 months. After 3 months, it will be removed endoscopically.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07675122
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