Diabetologie und Stoffwechsel 2015; 10 - P309
DOI: 10.1055/s-0035-1549815

German EndoBarrier® Registry – conception, structure, and current status

N Sauer 1, J Aberle 1, J Seufert 2, K Laubner 2
  • 1Universitätsklinikum Hamburg-Eppendorf, Endokrinologie und Diabetologie, Hamburg, Germany
  • 2Universitätsklinikum Freiburg, Endokrinologie und Diabetologie, Freiburg, Germany

Background: Obesity and type 2 diabetes mellitus are widespread and cost-intensive-diseases. Current conservative-therapeutic-concepts regularly fail to reach therapeutic-targets. Even though bariatric-surgery has proven to be effective, it is not suitable for all patients.

A less-invasive approach is the temporary, endoscopic duodenal-jejunal bypass-sleeve (DJBS, EndoBarrier®). It consists of a self-expanding-mesh and an impermeable-shell of 60 cm mimicking a Roux-en-Y gastric bypass with exclusion of the proximal-small-intestine. Up to now, small prospective-studies have demonstrated promising improvements of diabetes-control and body-weight-loss. However, long-term-safety and efficacy, have not been investigated in a sufficiently large cohort-of-patients. This task is the aim of a newly-established German-DJBL-(EndoBarrier®)-registry.

Methods: Long-term-data are collected by approximately 30 German-centers. An electronic-Case-Report-Form (eCRF) was designed to collect relevant-prespecified-items. All German sites that have implanted EndoBarrier® since 2010 were invited to provide patient-results. Data-acquisition is projected to a period of 5 years and a maximum of 1000 patients. An extension of data-acquisition is planned.

Results: Since CE-Mark-approval in 2010 approximately 400 patients have been treated with the DJBS in Germany. In addition to baseline-data, the registry collects information on weight-loss, safety, procedural-specificities, cardiovascular-events, improvement of glycemic-control, blood-pressure, lipids, obesity-associated-comorbidities and vitamin- and mineral-status. Currently data of approximately 70 patients have been included.

Conclusion: The German DJBL(EndoBarrier®)-registry will for the first time allow to derive important evidence on the value of the DJBL as a potentially new antidiabetic- and antiobese-treatment-option in a large-cohort of patients. It is urgently needed to complement the results of smaller-prospective-studies, also as a prerequisite by health-insurances for coverage-of-cost.