Duodenal-jejunal bypass sleeve for obesity and metabolic syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm study enrolling adults with obesity. Participants will have a DJBS implanted for three months and will be followed for nine months after removal to observe changes in obesity-related measures and metabolic factors. The trial will monitor safety and potential mechanisms related to weight loss and metabolism. Enrollment targets individuals with BMI criteria and metabolic syndrome, with specific exclusions to minimize risk. The lead sponsor is The Chinese University of Hong Kong, with CUHK Medical Centre as a collaborator, and sites are in Hong Kong.

Why it matters

Who can join: the full rules

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

Where it's running

• Chinese University of Hong Kong
  Shatin, Hong Kong Recruiting
• CUHK Medical Centre
  Shatin, Hong Kong Not yet recruiting

Study contacts

• Principal investigator: Stephen Ng, FRCSEd — Prince of Wales Hospital, the Chinese University of Hong Kong
• Study coordinator: Stephen Ng, FRCSEd
• Email: stephenng@surgery.cuhk.edu.hk
• Phone: +85235052956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.