A UK Registry for Metabolic and Bariatric Endoscopic Interventions

Obesity Clinical Trial

— UK-ENDOMAB  

Official title:

A UK Registry for Metabolic and Bariatric Endoscopic Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06305208
• Other study ID #: CCLR-23-018
• Status: Recruiting
• Start date: February 1, 2024
• Est. completion date: February 1, 2039

Study information

• Verified date: December 2023
• Source: Cleveland Clinic London
• Contact: Benjamin Norton, MD
• Phone: +442034237500
• Email: cclendoscopyresearch[@]ccf.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 1, 2039
• Est. primary completion date: February 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Any patient undergoing a primary or revisional bariatric or metabolic endoscopic procedure.

• Age = 18 years old

• Able to give written informed consent.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Obesity

Intervention

Device:
• Endoscopic gastric suturing
Endoscopic suturing of the stomach to reduce volume and promote weight loss with either the Apollo Overstitch or Overstitch Sx system.
• Endoscopic gastric plication
Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.
• 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
• 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.
• Duodenal mucosal resurfacing (DMR)
Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.
• 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.

Locations

Country	Name	City	State
United Kingdom	Cleveland Clinic London	London

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Clinic London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total body weight loss percentage (TBWL%)	For primary or revisional bariatric procedures: Percentage weight loss will be calculated using the following formula: TBWL% = [(weight at the baseline-weight at the end of time period)/weight at baseline] x 100	6-months, 1-, 2-, 3-, 5-years
Primary	Change in glycated haemoglobin (HbA1c; mmol/mol)	For primary metabolic procedures	6-months, 1-, 2-, 3-, 5-years
Primary	Change in the number and dose of anti-diabetic medications	For primary metabolic procedures	6-months, 1-, 2-, 3-, 5-years
Secondary	Procedure time (mins)		Baseline
Secondary	Inpatient stay (days)		6-months, 1-, 2-, 3-, 5-years
Secondary	Adverse events		30-day, 6-months, 1-, 2-, 3-, 5-years
Secondary	Change in systolic blood pressure measurements (mmHg)		6-months, 1-, 2-, 3-, 5-years
Secondary	Change in diastolic blood pressure measurements (mmHg)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in number and dose of anti-hypertensive medications (n)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in low-density lipoprotein cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in triglycerides (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in high-density lipoprotein cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in total cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in alanine transaminase (IU/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in aspartate aminotransferase (IU/L)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in Fibrosis-4 Index for Liver Fibrosis	The Fibrosis-4 Index for Liver Fibrosis provides a probability score for the presence of hepatic fibrosis. It is based on age, ALT, AST, and platelet count. The range of the score is wide but there are two main cut-offs point for prediction of advanced fibrosis (<1.3 and >2.67). Higher scores indicate a higher likelihood of advanced fibrosis.	6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in non-alcoholic fatty liver disease fibrosis score	The non-alcoholic fatty liver disease fibrosis score provides a probability score for the presence of hepatic fibrosis. It is based on age, body mass index, impaired fasting glucose, ALT, AST, albumin and platelet count. The range of the score is wide but there are two main cut-offs for prediction of advanced fibrosis (<-1.455 and >0.676). Higher scores indicate a higher likelihood of advanced fibrosis.	6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in weight (kg)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in body mass index (kg/m2)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in glycated haemoglobin (HbA1c; mmol/mol)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in number and dose of anti-diabetic medications (n)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in number and dose of anti-obesity medications (n)		6-months, 1-, 2-, 3-, 5-years
Secondary	Changes in health-related quality of life scores (EuroQol-5D-5L)	The EuroQol-5D-5L is a quality of life questionnaire that is composed of five questions scored 1-5 that do not have an arithmetic value and a visual analogue scale between 0-100. Participants are simply given a five digit code (e.g. 13455) and a visual analogue score (e.g. 78), which can then be interpreted through reference value sets in the corresponding country.	6-months, 1-, 2-, 3-, 5-years