Duodenal-jejunal bypass liner for treatment of T2DM and obesity: 4-year outcomes in the first National Health Service (NHS) EndoBarrier service
DOI:
https://doi.org/10.15277/bjd.2022.351Keywords:
EndoBarrier, duodenal–jejunal bypass liner, DJBL, obesity, type 2 diabetes, diabesity, bariatric surgeryAbstract
Background and aims: EndoBarrier is a 60cm duodenal-jejunal bypass liner endoscopically implanted for up to one year and designed to mimic the bypass part of roux-en-Y bariatric surgery. There is uncertainty concerning the extent to which improvements associated with EndoBarrier treatment are sus-tained once the liner has been removed. We aimed therefore to establish an EndoBarrier service for refractory diabesity and to continue to monitor the people with diabetes after EndoBarrier removal.
Methods: Between October 2014 and November 2017, we implanted 62 EndoBarriers in our NHS service. All had been removed by November 2018. Outcomes were monitored in a registry.
Results: As of November 2021, all patients reached three years after EndoBarrier removal and of these 43/62 (69%) (mean±SD age 51.6 ± 7.6 years, 55.8% male, 55.8% white ethnicity, median [IQR] diabetes duration 14.6 [8 – 21] years, 62.8% insulin-treated, mean±SD BMI 41.7±7.3 kg/m2) attended follow-up. In those who attended, during EndoBarrier implantation mean±SD HbA1c fell by 20.6±19.6 mmol/mol from 76.3±19.2 to 55.7±11.1 mmol/mol (p<0.001) (by 1.9±1.8% from 9.1±1.8% to 7.2±1.0% [p<0.001]), weight fell by 17.4±9.1 kg from 123.3±30.0 kg to 105.9±30.8 kg (p<0.001), BMI fell from 41.7±7.3 to 35.6±7.7 kg/m2 (p<0.001), systolic blood pressure from 138.7±14.4 to 125.4±14.7 mmHg (p<0.001), cholesterol from 4.6±1.0 to 3.7±0.7mmol/L (p<0.001), and serum alanine aminotransferase from 30.8±17.2 to 19.3±11.2 U/L (p<0.001). In those taking insulin median (IQR) total daily insulin dose reduced from 114 (54–180) to 20 (0–65) units (n=27, p<0.001); 10/27 (37%) insulin-treated people were able to discontinue insulin. Three years after EndoBarrier removal 33/43 (77%) maintained most of the improvement achieved with EndoBarrier whilst 10/43(23%) reverted to baseline. Of those deteriorating 9/10(90%) had depression and/or bereavement and/or major health problems/disability. 10/62(16%) required early Endo-Barrier removal for adverse events or symptoms; all 10 fully recovered after removal and most derived significant benefit.
Conclusions: Our data demonstrate that EndoBarrier is highly effective in people with refractory diabesity, with mainte-nance of significant improvement three years after removal in 77% of cases.
References
International Diabetes Federation. IDF diabetes atlas, 10th ed. 2021. https://www.diabetesatlas.org/ (accessed 09 August 2022).
United Kingdom Prospective Diabetes Study (UKPDS). Main Trial. See: https://www.dtu.ox.ac.uk/ukpds/ (accessed 09 August 2022).
UK Prospective Diabetes Study Group. Tight blood pressure control and risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 38. BMJ 1998;317:703–1. https://doi.org/10.1136/bmj.317. 7160.703
UK Prospective Diabetes Study Group. Efficacy of atenolol and captopril in reducing risk of macrovascular and microvascular complications in type 2 diabetes: UKPDS 39. BMJ 1998;317:713 20. https://doi.org/10.1136/bmj. 317.7160.713
UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treat-ment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet 1998 Sep 12;352(9131):837-53. https://doi.org/10.1016/S0140-6736(98)07019-6
Ryder REJ, Irwin SP, Burbridge W, et al. The United Kingdom's first NHS Endobarrier service for advanced diabesity: 1-year outcomes for all 62 treated patients. Br J Diabetes 2019;19:110–17. https://doi.org/10.15277/bjd.2019.226
Jirapinyo, Haas AV, Thompson CC. Effect of the duodenal-jejunal bypass liner on glycemic control in patients with type 2 diabetes with obesity: a meta-analysis with secondary analysis on weight loss and hormonal changes. Diabetes Care 2018;41(5):1106–15. https://doi.org/10.2337/dc17-1985
Brito JP, Montori VM, Davis AM. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by international diabetes organizations. JAMA 2017;317:635–636. https://doi.org/10.1001/jama. 2016.20563
Laubner K, Riedel N, Fink K, et al. Comparative efficacy and safety of the duodenal-jejunal bypass liner in obese patients with type 2 diabetes melli-tus: a case control study. Diabetes Obes Metab 2018;20(8):1868–77. https://doi.org/10.1111/dom.13300
Instructions for Use - EndoBarrier GI Liner with Delivery System - GID part number 50-10-00552 Rev N. http://gidynamics.com/wp-content/uploads/ 2017/09/50-10-00552-Rev-N-IFU-EB-GI-Liner-with-Delivery-System.pdf (ac-cessed 09 August 2022)
Ryder REJ, Yadagiri M, Burbridge W, et al. The United Kingdom’s first NHS EndoBarrier service for long-standing poorly controlled type 2 diabetes and obesity: outcomes one year after EndoBarrier removal. Br J Diabetes 2021;21:76-83. https://doi.org/10.15277/bjd.2021.295
de Jonge C, Rensen SS, Verdam FJ, et al. Endoscopic duodenal–jejunal by-pass liner rapidly improves type 2 diabetes. Obes Surg 2013;23:1354–60. https://doi.org/10.1007/s11695-013-0921-3
Betzel B, Homan J, Aarts EO, et al. Weight reduction and improvement in diabetes by the duodenal-jejunal bypass liner: a 198 patient cohort study. Surg Endosc 2017;31:2881–91. https://doi.org/10.1007/s00464-016-5299-6
Kaválková P, Mráz M, Trachta P, et al. Endocrine effects of duodenal–jejunal exclusion in obese patients with type 2 diabetes mellitus. J Endocrinol 2016;231(1):11–22. https://doi.org/10.1530/JOE-16-0206
Koehestanie P, Dogan K, Berends F, et al. Duodenal-jejunal bypass liner implantation provokes rapid weight loss and improved glycemic control, accompanied by elevated fasting ghrelin levels. Endosc Int Open 2014; 2(1): E21–E27. https://doi.org/10.1055/s-0034-1365222
Hayee B, Sen Gupta P, Anderson M, et al. Endoscopic proximal intestinal exclusion can improve non-alcoholic fatty liver disease (NAFLD) in patients with diabesity. Proceedings of the Digestive Diseases Week (DDW), San Diego, May 2016.
Ryder REJ, Sen Gupta P, Yadagiri M, et al. Improvement in Renal Function in Participants in the First UK National Health Service (NHS) EndoBarrier Service for Uncontrolled Diabesity. Curr Res Diabetes & Obes J 2021;15(1): 555902. https://doi.org/10.19080/CRDOJ.2021.15.555902
Ryder REJ, Yadagiri M, Burbridge W, et al. EndoBarrier treatment for long-standing type 2 diabetes and obesity: outcomes one year after EndoBarrier in 90 consecutively treated patients. Practical Diabetes 2022;39(3):13-16a. https://doi.org/10.1002/pdi.2393
Ryder REJ, Yadagiri M, Burbridge W, et al. Duodenal-jejunal bypass liner for the treatment of type 2 diabetes and obesity: 3-year outcomes in the First National Health Service (NHS) EndoBarrier Service. Diabetic Medicine 2022;39:e14827. https://doi.org/10.1111/dme.14827
American Society of Metabolic and Bariatric Surgery (ASMBS) Public/Pro-fessional Education Committee. Bariatric Surgery: Postoperative Concerns. Revised 02/07/2008 | Published: 05/23/2007. See: https://asmbs.org/resources/bariatric-surgery-postoperative-concerns
Ryder REJ, Sen Gupta P, Battelino T, et al. Duodenal jejunal bypass liner (DJBL) treatment for type 2 diabetes and obesity: glycaemic and CVD risk factor improvements vs risks in patients treated worldwide. Diabetologia 2022;65(Suppl 1):S29 – Abstract 54. See: https://link.springer.com/content/pdf/10.1007/s00125-022-05755-w.pdf (accessed 27 September 2022).
Ryder REJ. Oral presentation at EASD 2022: Duodenal jejunal bypass liner (DJBL) treatment for type 2 diabetes and obesity: glycaemic and CVD risk factor improvements vs risks in patients treated worldwide. See https://youtu.be/_VfIoaMn4GQ (accessed 27 September 2022).
EndoBarrier System Pivotal Trial (Rev B) (STEP-1). https://clinicaltrials.gov/ct2/show/NCT04101669 (accessed 09 August 2022).
Birmingham EndoBarrier Treated Patients. Pictures and video interviews obtained with written consent for online publication. https://abcd.care/re-source/birmingham-endobarrier-treated-patients (accessed 27 September 2022). NB the costs shown for the patient on pages 15-20 are from 2016.
Published
Issue
Section
License
Publish & Transfer of Copyright Agreement
For the mutual benefit and protection of the Author and the Journal Owner/Publisher it is necessary that the Author provides formal written Consent to Publish and Transfer of Copyright before publication of the Work.
