Safety and efficacy of the endoscopic duodenal–jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years

Quezada, Nicolás; Muñóz, Rodrigo; Morelli, Carla; Turiel, Dannae; Hernández, Julián; Pimentel, Fernando; Escalona, Alex

doi:10.1007/s00464-017-5672-0

Cited by 31 publications

(25 citation statements)

References 16 publications

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“…The desired biological effects stabilize after the first 12 months after implantation and DJBL removal results in weight regain and loss of glycemic control. This accords with data from a study with DJBL dwelling times up to 3 years [6]. A possible reason for the observed stabilization during dwelling time might be that the DJBL is tolerated better over time, patients have less abdominal complaints, early satiety diminishes, and therefore intake is increased.…”

Section: Discussionsupporting

confidence: 88%

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Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation

Betzel

Cooiman²,

Aarts³

et al. 2019

Surg Endosc

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Background The duodenal-jejunal bypass liner (DJBL) is an endoscopic device designed to induce weight loss and improve glycemic control. The liner is licensed for a maximum implant duration of 12 months. It might be hypothesized that extension of the dwelling time results in added value. The goals of our study were to determine weight change, change in glycemic control, and safety in patients with an intended 24 months of DJBL dwelling time. Methods Patients were initially selected for a 12-month implantation period. When no physical complaints or adverse events (AEs) occurred, motivated patients who responded well were selected for extension of dwelling time to 24 months. Patients underwent a control endoscopy 12 months after implantation and visited the outpatient clinic every 3 months up to explantation. Patients agreed to remove the DJBL when complaints or AEs occurred that could not be treated conservatively. Results Implantation was extended in 44 patients, and 24 (55%) patients completed the full 24 months. Twenty patients required early removal due to AEs. During dwelling time, body weight decreased significantly (15.9 kg; TBWL 14.6%). HbA1c decreased non-significantly (4.9 mmol/mol). The number of insulin users and daily dose of insulin both decreased significantly. At 24 months after removal, glycemic control had worsened, while body weight was still significantly lower compared to baseline. In total, 68% of the patients experienced at least one AE. Two patients developed a hepatic abscess. Conclusions DJBL treatment results in significant weight loss and improves glycemic control during implantation. The largest beneficial effects occur during the first 9-12 months after implantation. Extension of dwelling time to 24 months results only in stabilization of body weight and glycemic control. After explantation, weight improvements are maintained, but glycemic control worsens. As the cumulative risk of AEs increases with time, a maximal dwelling time of 12 months is advisable. Keywords Adverse events • Duodenal-jejunal bypass liner • Diabetes mellitus • Endobarrier • Hepatic abscess • Migration Abbreviations AE Adverse event ASGE American Society of Gastrointestinal Endoscopy DJBL Duodenal-jejunal bypass liner IGB Intragastric balloon SD Standard deviation T2DM Type 2 diabetes mellitus The increasing prevalence of obesity calls for the development of weight control measures. The current mainstay of treatment for morbid obesity is bariatric surgery. Roux-en-Y gastric bypass is one of the most performed bariatric procedures and has proven to be effective in inducing weight loss and controlling comorbidities such as type 2 diabetes mellitus (T2DM) and hypertension [1, 2]. As surgery carries the risk of intra-and postoperative adverse events (AEs), there

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Section: Discussionsupporting

confidence: 88%

“…The cohort study of Quezada et al describes an early removal rate of 86% before 36 months. In total, 29% of the early removals were due to AEs and 55 DJBL-related SAEs were observed in 80 patients of which three were hepatic abscess [6]. This suggests that all patients are at risk to develop (S)AEs during the complete dwelling time.…”

Section: Discussionmentioning

confidence: 99%

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation

Betzel

Cooiman²,

Aarts³

et al. 2019

Surg Endosc

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“…A second-generation EndoBarrier device with a 1 mm increase in barb length was trialed in 80 patients in Chile. The subjects initially consented to the implant for one year but were then given the opportunity to keep the device in for up to 3 years if tolerated [ 40 ]. The percentage excess weight losses in the complete population at 52 weeks (71 patients), 104 weeks (40 patients), and 156 weeks (11 patients) were 44 ± 16, 40 ± 22, and 39 ± 20, respectively ( p < 0.001).…”

Section: Future Developmentsmentioning

confidence: 99%

The EndoBarrier: Duodenal-Jejunal Bypass Liner for Diabetes and Weight Loss

Ruban

Ashrafian

Teare

2018

Gastroenterology Research and Practice

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The rapid rise of obesity and type 2 diabetes poses a global threat to healthcare and is a major cause of mortality and morbidity. Bariatric surgery has revolutionised the treatment of both these conditions but is invasive and associated with an increased risk of complications. The EndoBarrier is a device placed endoscopically in the duodenum, which is designed to mimic the effects of gastric bypass surgery with the aim of inducing weight loss and improving glycaemic control. This review outlines the current clinical evidence of the device, its efficacy, potential mechanisms of action, and utility in clinical practice.

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“…Future research should be focused on reimplantation strategies or a device that could remain in situ for longer, thereby providing a more permanent solution. A recent study already demonstrated implantation of a new prototype for up to 3 years in two obese subjects with T2DM, but high frequency and severity of AE's still preclude the use of the device for a period longer than 1 year [11]. Efforts are made to kick start further development to combat these issues.…”

Section: Efficacy and Safety Profilementioning

confidence: 99%

Endoluminal Techniques to Treat Obesity

Pruijssers¹,

Heurn²,

Bouvy³

2019

Recent Advances in Laparoscopic Surgery [Working Title]

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The prevalence of overweight and obesity increased dramatically during the past decades and now affects approximately 30% of people worldwide. Bariatric surgery has proven to be the most effective treatment modality for obesity in the long term. However, current surgical procedures are accompanied by a substantial risk of complications. Several endoluminal techniques have been developed to achieve weight loss in obese patients and claim to be as effective as surgery but safer. This chapter evaluates the efficacy and safety of innovative endoluminal techniques that are already available in clinical practice or in advanced stages of development. This chapter outlines their potential mechanism of action and their safety and efficacy in clinical practice, by reviewing the current literature.

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Safety and efficacy of the endoscopic duodenal–jejunal bypass liner prototype in severe or morbidly obese subjects implanted for up to 3 years

Abstract: This study shows significant and sustained weight loss after 3 years of treatment with the new DJBL. However, the high frequency and severity of AEs preclude the use of this prototype for periods longer than 1 year.

Cited by 31 publications

References 16 publications

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation

Clinical follow-up on weight loss, glycemic control, and safety aspects of 24 months of duodenal-jejunal bypass liner implantation

The EndoBarrier: Duodenal-Jejunal Bypass Liner for Diabetes and Weight Loss

Endoluminal Techniques to Treat Obesity

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