This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
Chinese University of Hong Kong
Shatin, Hong Kong
RECRUITINGCUHK Medical Centre
Shatin, Hong Kong
NOT_YET_RECRUITINGExcess body weight loss (%EBWL)
Percent excess body weight loss (%EBWL) from baseline to Month 12
Time frame: 12 months post-procedure
Incidence of adverse events
Adverse events relating to endoscopic intervention, graded according to the Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: within 30 days post-procedure
Body fat percentage
Changes in body fat percentage - measured by bioelectrical impedance analysis from baseline to Month 12
Time frame: 12 months post-procedure
Duodenal and faecal microbiome
changes in duodenal and faecal microbiome from baseline to Month 24
Time frame: 12 months post-procedure
Improvement of liver steatosis
Changes in CAP (S0:best - S3:worst) on Fibroscan
Time frame: 12 months post-procedure
Improvement of liver fibrosis
Changes in LMS (F0:best - F4:worst) on Fibroscan
Time frame: 12 months post-procedure
Change in Quality of Life
measured by 36-Item Short Form Survey (SF-36) questionnaire - (score 0:worst - 100:best) from baseline to Month 12
Time frame: 12 months post-procedure
HbA1c
Change in HbA1c (%) from baseline to Month 12
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Time frame: 12 months post-procedure
Duodenal mucosal changes
Changes in duodenal mucosal structures on histology from baseline to Month 12
Time frame: 12 months post-procedure