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Gastrointest Endosc. 2017 Jul 14. pii: S0016-5107(17)32090-4. doi: 10.1016/j.gie.2017.07.009. [Epub ahead of print]

Partial jejunal diversion using an incisionless magnetic anastomosis system: 1-year interim results in subjects with obesity and diabetes.

Author information

1
Department of Surgical Studies, Faculty of Medicine, University Hospital Ostrava, Czech Republic.
2
Department of Physiology and Pathophysiology, University of Ostrava Faculty of Medicine, Ostrava, Czech Republic.
3
Emerson Hospital, Concord, USA, Massachusetts General Hospital, Boston, USA.
4
West Bridgewater, Massachusetts, USA.
5
Brigham and Women's Hospital, Boston, MA, USA.

Abstract

BACKGROUND AND AIMS:

The majority of patients with type 2 diabetes mellitus (T2DM) have obesity. Studies show that bariatric surgery is superior to medical treatment for remission of T2DM. Nevertheless, very few patients undergo surgery, and a less-invasive endoscopic alternative is desirable.

METHODS:

This was a single-arm first-in-human pilot study, designed to evaluate the technical feasibility, safety, and clinical performance of the incisionless magnetic anastomosis system (IMAS) in creation of a partial jejunal diversion (PJD). Ten subjects with obesity and T2DM, pre-diabetes, or no diabetes were enrolled. A PJD to the ileum was attempted in all subjects under general anesthesia. The IMAS was delivered through the working channel of a colonoscope, with laparoscopic supervision. Subjects were not required to participate in an intensive lifestyle/diet management program. Endoscopic visualization of the anastomosis was obtained at 2, 6, and 12 months. Subject weight, glycemic profile, and metabolic panels were acquired at 0.5, 1, 2, 3, 6, 9, and 12 months.

RESULTS:

A PJD was created in all subjects, without device-related serious adverse events. The anastomosis remained widely patent in all subjects at 1 year. Average weight loss was 14.6% total weight loss (TWL) (40.2% excess weight loss [EWL]) at 12 months. A significant reduction in HbA1c was observed in all diabetic (1.9%) and prediabetic (1.0%) subjects, while reducing or eliminating the use of diabetes medications.

CONCLUSIONS:

Creation of a permanent anastomosis for PJD was safely performed in all subjects with the IMAS. This resulted in improvement in measures of hyperglycemia and progressive weight loss.

KEYWORDS:

6 key words]: metabolic therapy; GIE maximum word count; [NOTE; anastomosis; bariatric endoscopy; magnetic; obesity; type 2 diabetes

PMID:
28716404
DOI:
10.1016/j.gie.2017.07.009
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