Metabolic Syndrome (MetS), Obesity
Conditions
Keywords
duodenal-jejunal bypass sleeve, DJBS, DJBL
Brief summary
This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
Detailed 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.
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.
Sponsors
Chinese University of Hong Kong
CUHK Medical Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excess body weight loss (%EBWL) | 12 months post-procedure | Percent excess body weight loss (%EBWL) from baseline to Month 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | within 30 days post-procedure | Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) |
| Body fat percentage | 12 months post-procedure | Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 12 |
| Duodenal and faecal microbiome | 12 months post-procedure | changes in duodenal and faecal microbiome from baseline to Month 24 |
| Improvement of liver steatosis | 12 months post-procedure | Changes in CAP (S0:best - S3:worst) on Fibroscan |
| Improvement of liver fibrosis | 12 months post-procedure | Changes in LMS (F0:best - F4:worst) on Fibroscan |
| Change in Quality of Life | 12 months post-procedure | measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 12 |
| HbA1c | 12 months post-procedure | Change in HbA1c (%) from baseline to Month 12 |
| Duodenal mucosal changes | 12 months post-procedure | Changes in duodenal mucosal structures on histology from baseline to Month 12 |
Countries
Hong Kong
Contacts
CONTACTStephen Ng, FRCSEd
CONTACTIvy Study coordinator
PRINCIPAL_INVESTIGATORStephen Ng, FRCSEd
Prince of Wales Hospital, the Chinese University of Hong Kong
Outcome results
None listed