Clinical evaluation of the Endoscopic Duodenal-Jejunal Bypass Liner for management of type 2diabetes and obesity

Contains fulltext : 178929.pdf (publisher's version ) (Open Access)Radboud University, 12 december 2017Promotores : Drenth, J.P.H., Laarhoven, C.J.H.M. van Co-promotores : Barends, F.J., Groenen, M.J.M

[Caries explosion following bariatric surgery]

In a general dental practice, attention was drawn to a patient by numerous deep carious cavities following bariatric surgery. In the research literature, indications can be found for a negative influence of bariatric surgery on oral health. Risk factors for caries, such as the number of cariogenic bacteria in saliva, inadequate quantity and quality of saliva, gastrooesophageal reflux and vomiting may be become more pronounced. Additionally, dietary habits will change due to the altered anatomy of the gastro-intestinal tract. Negative effects of bariatric surgery on periodontal tissue have also been found. However, it is conceivable that patients who are overweight already have poorer oral health prior to bariatric surgery,due to lifestyle and dietary habits, than comparable people who are not overweight. Health education programmes prior to and following bariatric surgery seem to have a positive effect on oral health. Initiating more research into oral health related to bariatric surgery is recommended

Is reimplantation of the duodenal-jejunal bypass liner feasible?

Item does not contain fulltextBACKGROUND: The endoscopic ally implanted DJBL is a 60-cm impermeable fluoropolymer device, which prevents food from making contact with the proximal intestine. It was designed to induce weight loss and treat type 2 diabetes mellitus (T2DM). OBJECTIVES: To evaluate the feasibility, safety, and effectiveness of duodenal-jejunal bypass liner (DJBL) reimplantation. SETTING: Prospective, observational study was conducted at the department of surgery and gastroenterology of the Rijnstate hospital, Arnhem, the Netherlands, between 2009 and 2011. METHODS: Five obese patients with T2DM with body mass index (BMI) = Mass (kg) / height (m(2)), ranging from 30-35 kg/m(2) who completed the follow-up after their first implant and underwent removal of the DJBL after 6 months, were selected for reimplantation after an additional 18 months of follow-up. Weight loss, BMI, and HbA1 c were analyzed before and twelve months after reimplantation. RESULTS: In all 5 patients, the DJBL was implanted and explanted without any complications. Also the reimplantation and reexplantation occurred without any complications. Median weight decreased significantly from 105 kg to 95 kg, and BMI decreased from 33 to 29. The glycated hemoglobin (HbA1 c) level decreased from 8.4% to 7.3% by the first implantation but it wasn't significant. CONCLUSIONS: Reimplantation of DJBL is feasible, deemed safe, and showed additional weight loss

Chronic use of metamizole: not so safe after all?

Item does not contain fulltextMetamizole can be used in both short- and long-term pain relief therapies and has a relatively favourable safety profile compared with classic NSAIDs. Metamizole is also infamous because of its potential fatal adverse drug reaction, agranulocytosis. Although this risk varies, it is estimated to occur in less than one million metamizole prescriptions. We describe a case of a 68-year-old patient who developed leukopenia after using metamizole

Thoracic and abdominal pain in a 28-year-old woman with a failing kidney transplant

Contains fulltext : 195689.pdf (Publisher’s version ) (Closed access)This case report describes a young, immunocompromised patient who presented with thoracic pain. After an extensive workup, she was diagnosed with a varicella zoster virus infection with involvement of the gastric mucosa, pancreas and lungs for which she was treated with acyclovir. Although the viral load decreased significantly, the patient had persistent postherpetic neuralgia and nausea

The effect of the endoscopic duodenal-jejunal bypass liner on obesity and type 2 diabetes mellitus, a multicenter randomized controlled trial

OBJECTIVE: Investigate the safety and efficacy of 6 months' duodenal-jejunal bypass liner (DJBL) treatment in comparison with dietary intervention for obesity and type 2 diabetes mellitus (T2DM). BACKGROUND: The DJBL is a bariatric procedure involving an impermeable sleeve that is delivered endoscopically in the proximal intestine. This procedure not only is less invasive than conventional surgical techniques but also has beneficial effects on obesity and T2DM. METHODS: A multicenter randomized controlled trial was conducted. Seventy-seven patients with obesity and T2DM were included. Thirty-eight patients were randomized to 6 months' DJBL treatment in combination with dietary intervention (34 successfully implanted, 31 completed the study), 39 patients received only dietary intervention (controls, 35 completed the study). Total study duration for both groups was 12 months, including 6 months of post-DJBL removal follow-up. RESULTS: After 6 months, just before DJBL removal, the DJBL group had lost 32.0% [22.0%-46.7%] of their excess weight versus 16.4% [4.1%-34.6%] in the control group (P < 0.05). Glycated hemoglobin A1c levels improved to 7.0% [6.4%-7.5%] in the DJBL group and to 7.9% [6.6%-8.3%] in the control group (P < 0.05). In addition, 85.3% of DJBL patients showed decreased postprandial glucose excursions versus 48.7% of control patients (P < 0.05). At 12 months, excess weight loss of the DJBL group was 19.8% [10.6%-45.0%] versus 11.7% [1.4%-25.4%] in the control group (P < 0.05). HbA1c was 7.3% [6.6%-8.0%] versus 8.0% [6.8%-8.8%], DJBL versus control respectively (P = ns). CONCLUSIONS: The DJBL is a safe and effective alternative to invasive bariatric procedures. Six months of DJBL treatment combined with diet leads to superior weight loss and improvement of T2DM when compared with diet alone

Safety experience with the duodenal-jejunal bypass liner: an endoscopic treatment for diabetes and obesity

Item does not contain fulltextBACKGROUND: The duodenal-jejunal bypass liner (DJBL) is a new, device-based endoscopic treatment for type 2 diabetes mellitus (T2DM) and obesity. OBJECTIVE: To report serious safety events of subjects treated with the DJBL while offering a simple guideline to mitigate risk. DESIGN: Single-center observational study. SETTING: Tertiary referral center. PATIENTS: For commercial use, patients were eligible for implantation of the DJBL when they met the following criteria: age 18 to 65 years, body mass index 28 to 45 kg/m(2), T2DM, and negative serum Helicobacter pylori test. INTERVENTIONS: Endoscopic implantation of the DJBL. MAIN OUTCOME MEASUREMENTS: Adverse events, serious adverse events, early explantation. RESULTS: Between October 2007 and January 2014, 152 of 165 planned implantations (92%) and 94 explantations were performed in our center. Significant weight loss and improvement in T2DM and other cardiovascular parameters were achieved. Early removal of the device occurred because of persistent GI symptoms in 16 patients (11%). Serious adverse events were observed in a subset of patients: 7 GI bleeds, 5 of which required early removal; 2 cases of pancreatitis; 1 case of hepatic abscess; and 1 obstruction of the sleeve. Explantation resulted in an esophageal tear in 2 cases. LIMITATIONS: Single-center study. CONCLUSION: The DJBL improves glycemic control while causing weight loss. The safety profile of the DJBL demonstrates a reasonable tolerability profile. However, serious safety adverse events can occur. Patient selection, expert use of the device at placement and removal, and the supportive care of an experienced multidisciplinary team are key for safe and effective use of the DJBL

Changes in glycemic control and body weight after explantation of the duodenal-jejunal bypass liner

Item does not contain fulltextBACKGROUND AND AIMS: The duodenal-jejunal bypass liner (DJBL) is an endoscopic device that induces weight loss and improves glycemic control in patients with type 2 diabetes mellitus (T2DM). The aim of the current study was to assess the effects of DJBL explantation on glycemic control and body weight. METHODS: This prospective, observational study included only patients with T2DM who had the DJBL implanted for at least 6 months and had a follow-up of at least 12 months after explantation. The primary endpoints were changes in glycosylated hemoglobin A1c (HbA1c) and body weight during the 12 months after explantation. Secondary endpoints were changes in fasting plasma glucose, blood pressure, and plasma lipid levels. RESULTS: In total, 59 patients completed the 12-month follow-up after explantation. During this period body weight increased by 5.6 (standard deviation, 6.4) kg (P < .001) and HbA1c rose from 65 (SD 17) to 70 (SD 20) mmol/mol (P < .001). However, body weight remained 8.0 (SD 8.6) kg (P < .001) lower than before implantation, that is, corresponding to a net total body weight loss of 7.4% (SD 7.6) (P < .001). Although HbA1c was significantly higher 12 months after explantation compared with baseline and the mean daily dose of insulin used was comparable, the number of patients on insulin remained significantly lower than before implantation. CONCLUSIONS: Explantation of the DJBL is associated with weight gain and worsening of glycemic control, although some beneficial effects remained detectable 12 months after explantation. A change in strategy is needed to preserve the beneficial effects of DJBL treatment. (Clinical trial registration number: 746\100111.)

Fast-track bariatric surgery improves perioperative care and logistics compared to conventional care

Contains fulltext : 155265.pdf (publisher's version ) (Closed access)BACKGROUND: Due to the increased incidence of morbid obesity, the demand for bariatric surgery is increasing. Therefore, the methods for optimising perioperative care for the improvement of surgical outcome and to increase efficacy are necessary. The aim of this prospective matched cohort study is to objectify the effect of the fast-track surgery (FTS) programme in patients undergoing primary Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) surgery compared to conventional perioperative care (CPC). METHODS: This study compared the perioperative outcome data of two groups of 75 consecutive morbid obese patients who underwent a primary LRYGB according to international guidelines in the periods January 2011-April 2011 (CPC group) and April 2012-June 2012 (FTS group). The two groups were matched for age and sex. Primary endpoints were surgery and hospitalisation time, while secondary endpoints were intraoperative medication use and complication rates. RESULTS: Baseline patient characteristics for age, sex, weight and ASA classification were similar (p > 0.05) for CPC and FTS patients. BMI and waist circumference were significantly lower (p < 0.05) in the FTS compared to CPC. The total time from arrival at the operating room to the arrival at the recovery was reduced from 119 to 82 min (p < 0.001). Surgery time was reduced from 80 to 56 min (p < 0.001); mean hospital stay was reduced from 65 to 43 h (p < 0.001). Major complications occurred in 3 versus 4 % in the FTS and CPC, respectively. CONCLUSIONS: The introduction of a fast-track programme after primary LRYGB improves short-term recovery and may reduces direct hospital-related resources