A UK Registry for Metabolic and Bariatric Endoscopic Interventions

Обзор

In the UK alone, obesity is a major health problem with more than one quarter of adults estimated to be obese. Obesity promotes the development of many serious diseases including diabetes, heart disease, kidney disease, and increased risk of some cancers. Patients living with obesity also suffer from significant symptoms that impact their life including shortness of breath, back pain, poor mobility, and poor mental health. Traditional methods to help lose weight include low calorie diets and increased exercise. These may be effective in the short-term, but due to powerful biological mechanisms they are hard to maintain over the long-term and most individuals are unable to achieve normal weight. This means many people may need bariatric surgery that is highly effective at lowering body weight, but it is associated with complications and not all patients will want or be able to undergo surgery. This has led to the development of many new obesity treatments that are completed with an endoscope. An endoscope is a thin flexible tube that has a camera at the end. It is inserted through the mouth and into the stomach and small bowel. There are various procedures that can be done at the time of endoscopy that have been shown to be effective with a low number of side-effects. These are still relatively new compared to more traditional treatments and only a small number of doctors can perform them within the UK. Due to these limitations, the aim of this registry is to obtain real-world information on the safety and effectiveness of these procedures across the UK. The investigators hope over time this will improve the knowledge of clinicians about treating obesity with endoscopy and support future access and funding to these treatments.

Подробное описание

This is a national, multi-centre, prospective, UK registry that aims to determine the safety and efficacy of metabolic and bariatric endoscopic procedures used in the treatment of obesity and related complications. The investigators will do this by determining the effect of primary bariatric procedures (gastroplasty, intragastric balloons (IGB)), revisional bariatric procedures (Transoral outlet reduction endoscopy (TORe), gastroplasty revision), and primary metabolic procedures (Duodenal Mucosal Resurfacing (DMR)), completed by endoscopists within the UK.

The objective of this registry is to collect demographic, procedural and follow-up outcome data on the use of metabolic and bariatric endoscopic procedures in patients with obesity and/or obesity-related complications. This registry will provide real-life outcomes on the use of these novel endoscopic devices from multiple centres participating across the UK to provide longer-term safety and efficacy data. In addition, the registry will enable development of a UK-wide research network to support further research, innovation, and training into metabolic and bariatric endoscopy.

Вмешательства

• Устройство Endoscopic gastric suturing
  Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.
• Устройство Endoscopic gastric plication
  Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.
• Устройство Revisional gastroplasty
  Endoscopic suturing or plication of the stomach among patients who have previously undergone gastroplasty, sleeve gastrectomy, or Roux-en-Y gastric bypass to restrict the stomach and promote weight loss
• Устройство Transoral outlet reduction endoscopy (TORe)
  Reduction of the size of the gastro-jejunal anastomosis among patients who have previously undergone Roux-en-Y gastric bypass to promote weight loss. A variety of techniques may be used alone or in isolation including suturing (Apollo Overstitch), plication (POSE), argon photocoagulation, and endoscopic submucosal resection/dissection.
• Устройство Duodenal mucosal resurfacing (DMR)
  Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.
• Устройство Intragastric balloon(s)
  The insertion of an intragastric implant into the stomach, which is subsequently filled with air or water to promote weight loss. Several intragastric balloons are available including Allurion, Heliosphere, Obalon, Orbera, and Spatz.

Первичные конечные точки

• Total body weight loss percentage (TBWL%) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Change in glycated haemoglobin (HbA1c; mmol/mol) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Change in the number and dose of anti-diabetic medications [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]

Вторичные конечные точки (12)

• Procedure time (mins) [Срок оценки: Baseline]
• Inpatient stay (days) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Adverse events [Срок оценки: 30-day, 6-months, 1-, 2-, 3-, 5-years]
• Change in systolic blood pressure measurements (mmHg) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Change in diastolic blood pressure measurements (mmHg) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in number and dose of anti-hypertensive medications (n) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in low-density lipoprotein cholesterol (mmol/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in triglycerides (mmol/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in high-density lipoprotein cholesterol (mmol/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in total cholesterol (mmol/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in alanine transaminase (IU/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]
• Changes in aspartate aminotransferase (IU/L) [Срок оценки: 6-months, 1-, 2-, 3-, 5-years]

Критерии участия

Критерии включения

• Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.
• Age ≥ 18 years old
• Able to give written informed consent.

Критерии исключения

• Any bariatric or metabolic endoscopic procedure performed outside the UK.
• Any bariatric or metabolic endoscopic procedure not currently listed within the registry protocol or agreed by the steering committee.
• Unable to provide written informed consent.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Великобритания · 1 центр

• Cleveland Clinic London — London

Идентификаторы

NCT: NCT06305208 · CCLR-23-018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗