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Not yet recruiting NCT07675122

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

No phase Interventional Obesity Metabolic Syndrome (MetS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implantation of duodenal-jejunal bypass sleeve.
Who it may be relevant to
Registry conditions: Obesity, Metabolic Syndrome (MetS). Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Endoscopic Duodenal-jejunal Bypass Sleeve for Treatment of Obesity and Metabolic Syndrome - a Multicenter Pilot Study

Overview

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

  • Procedure Implantation 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.

Primary outcome measures

  • Excess body weight loss (%EBWL) [Time frame: 12 months post-procedure]
Secondary outcome measures (8)
  • Incidence of adverse events [Time frame: within 30 days post-procedure]
  • Body fat percentage [Time frame: 12 months post-procedure]
  • Duodenal and faecal microbiome [Time frame: 12 months post-procedure]
  • Improvement of liver steatosis [Time frame: 12 months post-procedure]
  • Improvement of liver fibrosis [Time frame: 12 months post-procedure]
  • Change in Quality of Life [Time frame: 12 months post-procedure]
  • HbA1c [Time frame: 12 months post-procedure]
  • Duodenal mucosal changes [Time frame: 12 months post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 2 centers
  • Chinese University of Hong Kong — Shatin
  • CUHK Medical Centre — Shatin

Identifiers

NCT: NCT07675122 · CRE-2026.190

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗