A UK Registry for Metabolic and Bariatric Endoscopic Interventions (UK-ENDOMAB)

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Device: Endoscopic gastric suturing; Device: Endoscopic gastric plication; Device: Intragastric balloon(s); Device: Revisional gastroplasty; Device: Transoral outlet reduction endoscopy (TORe); Device: Duodenal mucosal resurfacing (DMR)

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Benjamin Norton, MD; Phone Number: +442034237500; Email: cclendoscopyresearch@ccf.org
• Study Contact Backup: Name: Fiona Makia; Phone Number: +442034237500; Email: cclresearch@ccf.org

Study Locations

• United Kingdom
  • London, United Kingdom, SW1X 7HY
    • Recruiting
    • Cleveland Clinic London
    • Principal Investigator: Rehan Haidry, MD
    • Contact: Benjamin Norton, MD; Email: cclendoscopyresearch@ccf.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients within the United Kingdom (UK) who have, or plan to, undergo a primary or revisional bariatric or metabolic endoscopic procedure for the treatment of obesity or metabolic disease in the UK

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary bariatric endoscopic procedures	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.; Other Names: Endoscopic sleeve gastroplasty (ESG; Apollo Overstitch); Device: Endoscopic gastric plication; Endoscopic plication of the stomach to reduce volume and promote weight loss with either the POSE or Endomina system.; Other Names: Primary obesity surgery endoluminal (POSE), Endomina system; Device: 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.
Revisional bariatric endoscopic procedures	Device: 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; Device: 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.
Primary metabolic endoscopic procedures	Device: Duodenal mucosal resurfacing (DMR); Endoscopic ablation of the post-ampullary duodenal mucosal to enhance improvement in glycaemic control among patients with type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in glycated haemoglobin (HbA1c; mmol/mol)	For primary metabolic procedures	6-months, 1-, 2-, 3-, 5-years
Change in the number and dose of anti-diabetic medications	For primary metabolic procedures	6-months, 1-, 2-, 3-, 5-years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure time (mins)		Baseline
Inpatient stay (days)		6-months, 1-, 2-, 3-, 5-years
Adverse events		30-day, 6-months, 1-, 2-, 3-, 5-years
Change in systolic blood pressure measurements (mmHg)		6-months, 1-, 2-, 3-, 5-years
Change in diastolic blood pressure measurements (mmHg)		6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-hypertensive medications (n)		6-months, 1-, 2-, 3-, 5-years
Changes in low-density lipoprotein cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Changes in triglycerides (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Changes in high-density lipoprotein cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Changes in total cholesterol (mmol/L)		6-months, 1-, 2-, 3-, 5-years
Changes in alanine transaminase (IU/L)		6-months, 1-, 2-, 3-, 5-years
Changes in aspartate aminotransferase (IU/L)		6-months, 1-, 2-, 3-, 5-years
Changes in weight (kg)		6-months, 1-, 2-, 3-, 5-years
Changes in body mass index (kg/m2)		6-months, 1-, 2-, 3-, 5-years
Changes in glycated haemoglobin (HbA1c; mmol/mol)		6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-diabetic medications (n)		6-months, 1-, 2-, 3-, 5-years
Changes in number and dose of anti-obesity medications (n)		6-months, 1-, 2-, 3-, 5-years
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
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
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

Collaborators and Investigators

• Sponsor: Cleveland Clinic London
• Investigators: Principal Investigator: Rehan Haidry, MD, Cleveland Clinic London

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): February 1, 2034
• Study Completion (Estimated): February 1, 2039

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: CCLR-23-018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No