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

Официальное название

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

Обзор

This study is designed to evaluate the efficacy, safety, and mechanisms of duodenal-jejunal bypass sleeve in patients with obesity

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Excess body weight loss (%EBWL) [Срок оценки: 12 months post-procedure]

Вторичные конечные точки (8)

• Incidence of adverse events [Срок оценки: within 30 days post-procedure]
• Body fat percentage [Срок оценки: 12 months post-procedure]
• Duodenal and faecal microbiome [Срок оценки: 12 months post-procedure]
• Improvement of liver steatosis [Срок оценки: 12 months post-procedure]
• Improvement of liver fibrosis [Срок оценки: 12 months post-procedure]
• Change in Quality of Life [Срок оценки: 12 months post-procedure]
• HbA1c [Срок оценки: 12 months post-procedure]
• Duodenal mucosal changes [Срок оценки: 12 months post-procedure]

Критерии участия

Критерии включения

• Body mass index (BMI) ≥27.5kg/m2; or BMI ≥25 kg/m2 with metabolic syndrome

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 2 центра

• Chinese University of Hong Kong — Shatin
• CUHK Medical Centre — Shatin

Идентификаторы

NCT: NCT07675122 · CRE-2026.190

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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