BackgroundThe duodenum has become a metabolic treatment target through bariatric surgery learnings and the specific observation that bypassing, excluding or altering duodenal nutrient exposure elicits favourable metabolic changes. Duodenal mucosal resurfacing (DMR) is a novel endoscopic procedure that has been shown to improve glycaemic control in people with type 2 diabetes mellitus (T2D) irrespective of body mass index (BMI) changes. DMR involves catheter-based circumferential mucosal lifting followed by hydrothermal ablation of duodenal mucosa. This multicentre study evaluates safety and feasibility of DMR and its effect on glycaemia at 24 weeks and 12 months.MethodsInternational multicentre, open-label study. Patients (BMI 24–40) with T2D (HbA1c 59–86 mmol/mol (7.5%–10.0%)) on stable oral glucose-lowering medication underwent DMR. Glucose-lowering medication was kept stable for at least 24 weeks post DMR. During follow-up, HbA1c, fasting plasma glucose (FPG), weight, hepatic transaminases, Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), adverse events (AEs) and treatment satisfaction were determined and analysed using repeated measures analysis of variance with Bonferroni correction.ResultsForty-six patients were included of whom 37 (80%) underwent complete DMR and 36 were finally analysed; in remaining patients, mainly technical issues were observed. Twenty-four patients had at least one AE (52%) related to DMR. Of these, 81% were mild. One SAE and no unanticipated AEs were reported. Twenty-four weeks post DMR (n=36), HbA1c (−10±2 mmol/mol (−0.9%±0.2%), p<0.001), FPG (−1.7±0.5 mmol/L, p<0.001) and HOMA-IR improved (−2.9±1.1, p<0.001), weight was modestly reduced (−2.5±0.6 kg, p<0.001) and hepatic transaminase levels decreased. Effects were sustained at 12 months. Change in HbA1c did not correlate with modest weight loss. Diabetes treatment satisfaction scores improved significantly.ConclusionsIn this multicentre study, DMR was found to be a feasible and safe endoscopic procedure that elicited durable glycaemic improvement in suboptimally controlled T2D patients using oral glucose-lowering medication irrespective of weight loss. Effects on the liver are examined further.Trial registration numberNCT02413567

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Gastrobronchial fistula (GBF) is a rare surgical complication after bariatric surgery. We aimed to identify the clinical aspects of GBF and establish diagnostic and treatment strategies. A literature search was conducted in December 2013, in the PubMed electronic database. Eleven studies were selected, comprising a total of 36 patients. Most patients presented with a gastric leak prior to the diagnosis of GBF. Mean period until diagnosis was 7.2 months, and main presenting symptoms were productive cough (n = 13) and subphrenic abscess (n = 12). Endoscopic treatment was successful in 18 out of 20 patients, with minimal complication. Surgical treatment was successful in 17 cases with significant complications. GBF can be effectively treated with both endoscopic and surgical approach; however, surgical treatment can be associated with more complication.

This novel endoscopic procedure is safe, feasible, and effective, avoiding re-operation, allowing early oral feeding and discharge.

Roux-en-Y gastric bypass (RYGB) is the most commonly performed bariatric procedure. Despite its high efficacy, some patients regain part of their lost weight. Several endoscopic therapies have been introduced as alternatives to treat weight regain, but most of the articles are relatively small with unclear long-term data. To systematically assess the efficacy of endoscopic therapies for weight regain after RYGB. We searched MEDLINE, EMBASE, Scopus, Web of Science, Cochrane, OVID, CINAHL/EBSCo, LILACS/Bireme, and gray literature. Primary outcomes were absolute weight loss (AWL), excess weight loss (EWL), and total body weight loss (TBWL). Thirty-two studies were included in qualitative analysis. Twenty-six described full-thickness (FT) endoscopic suturing and pooled AWL, EWL, and TBWL at 3 months were 8.5 ± 2.9 kg, 21.6 ± 9.3%, and 7.3 ± 2.6%, respectively. At 6 months, they were 8.6 ± 3.5 kg, 23.7 ± 12.3%, and 8.0 ± 3.9%, respectively. At 12 months, they were 7.63 ± 4.3 kg, 16.9 ± 11.1%, and 6.6 ± 5.0%, respectively. Subgroup analysis showed that all outcomes were significantly higher in the group with FT suturing combined with argon plasma coagulation (APC) (p < 0.0001). Meta-analysis included 15 FT studies and showed greater results. Three studies described superficial-thickness suturing with pooled AWL of 3.0 ± 3.8, 4.4 ± 0.07, and 3.7 ± 7.4 kg at 3, 6, and 12 months, respectively. Two articles described APC alone with mean AWL of 15.4 ± 2.0 and 15.4 ± 9.1 kg at 3 and 6 months, respectively. Full-thickness suturing is effective at treating weight regain after RYGB. Performing APC prior to suturing seems to result in greater weight loss. Head-to-head studies are needed to confirm our results. Few studies adequately assess effectiveness of other endoscopic techniques.

ObjectiveHydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D).DesignEligible patients (haemoglobin A1c (HbA1c) 59–86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks.ResultsOverall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was −10.4 (18.6) mmol/mol in DMR group versus −7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was −5.4 (5.6)% in DMR group versus −2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was –6.6 mmol/mol (17.5 mmol/mol) versus –3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was –5.4% (6.1%) versus –2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient.ConclusionsDMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG.Trial registration numberNCT02879383

Short-term stimulation of the LES in patients with GERD significantly increases resting LESP without affecting esophageal peristalsis or LES relaxation. Electrical stimulation of the LES may offer a novel therapy for patients with GERD.