First Risk–Benefit Data from the Worldwide Endobarrier Registry

Abstract

Uncertainty exists about risk:benefit of proximal intestinal exclusion with Endobarrier (EB), a novel endoscopic duodenal jejunal liner device for obesity, both with and without diabetes. In view of this, during 2017, an independent, secure, on-line registry was established under the auspices of the Association of British Clinical Diabetologists, for the collection of safety and efficacy data worldwide. As of December 2017, data had been entered on 403 patients {age 51.3 ± 11.8 year, 62% male, 89% europid, 74% diabetes, BMI 42.6 ± 10.2 kg/m2} from 13 centres in 4 countries: Australia, Austria, Czech Republic and United Kingdom. EB led to many benefits, including: in those with both baseline and explant data, mean ± SD weight fell by 14.5 ± 10.3 kg from 125.3 ± 26.7 to 110.8 ± 26.4 kg (n = 265 p<0.001), HbA1c by 1.4 ± 1.6%, from 8.7 ± 1.8 to 7.2 ± 1.2% (n = 195, p<0.001) and systolic BP fell from 138.5 ± 18.1 to 130.0 ± 17.2 mmHg (n = 149, <0.001). There were 23 (5.7%) serious adverse events (SAE) and 37 (9.2%) less serious AEs (Table). All SAE patients made a full recovery. The median (range) weight loss in those with early removal for GI bleed was 6.5 (0-29) and with early removal for liver abscess was 17.2 (7-21) kg. Some SAEs could have been avoided if patients had adhered to guidelines. The benefits of EB therapy are likely to reduce the complications of diabetes. This 1st international data from the EB registry suggests that the likely benefits of EB, far outweigh the risks. Disclosure R.E.J. Ryder: Other Relationship; Self; AstraZeneca. Speaker's Bureau; Self; Bioquest, Janssen Pharmaceuticals, Inc.. Other Relationship; Self; Janssen Pharmaceuticals, Inc.. Advisory Panel; Self; Novo Nordisk A/S. L. Munro: None. J.J. McMaster: None. J. Bessell: None. J.M. Bascomb: None. J.E. Collins: None. L. Kow: None. J. Chisholm: None. H. Sourij: Speaker's Bureau; Self; Boehringer Ingelheim GmbH, Novo Nordisk A/S, Amgen Inc., Sanofi, MSD K.K.. Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH, MSD K.K., GI Dynamics Inc.. P.N. Pferschy: None. J.P. Teare: Research Support; Self; GI Dynamics Inc.. J.C. Mason: None. J.P. Byrne: None. M.C. Wyres: None. M.L. Cull: None. W. Burbridge: Other Relationship; Self; Menarini Group. S.P. Irwin: None. M. Yadagiri: None. E. Fogden: None. M. Anderson: None. P. Sen Gupta: None. M. Benes: None.