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

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 out-patient 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.

Is reimplantation of the duodenal-jejunal bypass liner feasible?

BACKGROUND: 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.

Long-term effects of laparoscopic Roux-en-Y gastric bypass on diabetes mellitus, hypertension and dyslipidaemia in morbidly obese patients.

BACKGROUND: Severely obese patients have an increased risk for developing metabolic complications such as type 2 diabetes mellitus (T2DM), dyslipidaemia (DL) and hypertension (HT). The aim of the present study is to research the effect of a primary laparoscopic Roux-en-Y gastric bypass (LRYGB) on T2DM, HT and DL in the long-term. METHODS: Fifty-two out of 89 (58 %) adult severely obese patients with T2DM who had received a LRYGB between January 2000 and December 2008 were evaluated. Primary outcome of evaluation was remission of T2DM according to the definition of 2009 consensus statement. Complete remission was defined as achievement fasting plasma glucose (FPG) of <5.6 mmol/l (<100.8 mg/dL) and HbA1c <42 mmol/mol (<6.0 %)) without glucose-lowering medication for at least 1 year. Partial remission was defined as a FPG of 5.6-6.9 mmol/l (100.8-124.2 mg/dL) and HbA1c 42-48 mmol/mol (6.0-6.5 %), without glucose-lowering medication for at least 1 year. Remission of T2DM was considered if the patient met the criteria for complete or partial remission. Secondary outcomes were remission of HT, DL and changes in medication use. RESULTS: Patients had a mean age of 47.5 ± 9.6 years, body mass index of 46.6 ± 6.4 kg/m(2) and a mean duration of T2DM of 6.1 ± 5.4 years at the time of surgery. The mean post-operative follow-up period was 6.9 ± 2.3 years. At the end of the follow-up, mean weight loss was 60 ± 24 % excess weight loss (EWL) and 26 ± 10 % total body weight loss (TBWL). Mean HbA1c level had significantly decreased from 64.8 ± 19.7 mmol/mol to 46.4 ± 12.9 mmol/l (p < 0.0001). Overall medication use was reduced from 85 % to 37 % of the patients (p < 0.0001), while the number of insulin users was reduced from 40 % to 6 % (p < 0.0001). Nineteen percent of the patients had a relapse of T2DM during follow-up. Pre-operative HbA1ac level (odds ratio 0.911, p = 0.020) and duration of T2DM (odds ratio 0.637, p = 0.010) were independent risk factors for failed remission of T2DM. The number of patients with HT was significantly reduced from 73 % to 54 % (p = 0.042), and number of patients with DL was non-significantly decreased from 71 % to 54 % (p = 0.068). CONCLUSIONS: The laparoscopic RYGB operation results in a sustained EWL of 60 % (26 % TBWL) with 52 % long-term remission of T2DM. However, 19 % of the patients had a relapse of their T2DM. Furthermore, HT and DL improved markedly.