BACKGROUND & AIMS: Swallowed topical-acting corticosteroids are recommended as first-line therapy for eosinophilic esophagitis (EoE). Asthma medications not optimized for esophageal delivery are sometimes effective, although given offlabel. We performed a randomized, placebo-controlled trial to assess the effectiveness and tolerability of a budesonide orodispersible tablet (BOT), which allows the drug to be delivered to the esophagus in adults with active EoE. METHODS: We performed a double-blind, parallel study of 88 adults with active EoE in Europe. Patients were randomly assigned to groups that received BOT (1 mg twice daily; n ¼ 59) or placebo (n ¼ 29) for 6 weeks. The primary end point was complete remission, based on clinical and histologic factors, including dysphagia and odynophagia severity 2 on a scale of 0-10 on each of the 7 days before the end of the double-blind phase and a peak eosinophil count <5 eosinophils/high power field. Patients who did not achieve complete remission at the end of the 6-week double-blind phase were offered 6 weeks of open-label Gastroenterology 2019;157:74-86 CLINICAL AT treatment with BOT (1 mg twice daily). RESULTS: At 6 weeks, 58% of patients given BOT were in complete remission compared with no patients given placebo (P < .0001). The secondary end point of histologic remission was achieved by 93% of patients given BOT vs no patients given placebo (P < .0001). After 12 weeks, 85% of patients had achieved remission. Six-week and 12-week BOT administration were safe and well tolerated; 5% of patients who received BOT developed symptomatic, mild candida, which was easily treated with an oral antifungal agent. CONCLUSIONS: In a randomized trial of adults with active EoE, we found that budesonide oral tablets were significantly more effective than placebo in inducing clinical and histologic remission. Eudra-CT number 2014-001485-99; ClinicalTrials.gov ID NCT02434029.
BACKGROUND Continuous delivery to the jejunum of levodopa-carbidopa is a promising therapy in patients with advanced Parkinson's disease, as it reduces motor fluctuation. Percutaneous endoscopic gastrostomy and jejunal tube (PEG-J) placement is a suitable option for this. However, studies focused in PEG-J management are lacking. OBJECTIVES We report our experience regarding this technique, including technical success, adverse events and outcomes, in patients with advanced Parkinson's disease. METHODS Twenty-seven advanced Parkinson's disease patients (17 men, median age: 64 years, median disease duration: 11 years) were included in a retrospective study from June 2007 to April 2015. The median follow-up period was 48 months (1-96). RESULTS No adverse events were noted during and after nasojejunal tube insertion (to assess treatment efficacy). After a good therapeutic response, a PEG-J was placed successfully in all patients. The PEG tube was inserted according to Ponsky's method. The jejunal extension was inserted during the same procedure in all patients. Twelve patients (44%) experienced severe adverse events related to the PEG-J insertion, which occurred after a median follow-up of 15.5 months. Endoscopy was the main treatment modality. Patients who experienced severe adverse events had a higher comorbidity score (p = 0.011) but were not older (p = 0.941) than patients who did not. CONCLUSIONS While all patients responded well to levodopa-carbidopa regarding neurological outcomes, gastro-intestinal severe adverse events were frequent and related to comorbidities. Endoscopic treatment is the cornerstone for management of PEG-J related events. In conclusion, clinicians and endoscopists, as well as patients, should be fully informed of procedure-related adverse events and patients should be followed in centres experienced in their management.
Background and study aims Patients with painful chronic pancreatitis (CP) and distal main pancreatic duct (MPD) stricture are considered candidates for treatment using a single plastic stent insertion. Multiple side-by-side stents have been proposed as an alternative treatment but comparative studies are lacking. The aim of this retrospective study is to assess differences in characteristics and treatment outcomes in patients with CP and MPD strictures treated with a different number of stents during the stenting period. Patients and methods Patients with painful CP and distal MPD obstruction requiring endoscopic treatment (01.2004 – 12.2012) were considered. The study population was divided in three groups: Patients treated with (A) exclusively one stent; (B) one or two stents; and (C) exclusively two stents during the stenting period. Patient characteristics and treatment outcomes were retrospectively assessed. Results Among 284 patients, 85 were selected according to inclusion criteria (Group A: 18, Group B: 35, Group C: 32). Median follow-up duration was 84 months. The median number of endoscopic procedures needed was higher for group B [3 (A) vs. 3 (C) vs. 4 (B), P = 0.001]. Regarding outcome, successful endoscopic treatment was lower in Group C (50 % vs. 88.2 % and 74.2 % for groups A and B, respectively; P = 0.02). This difference was attributed to better clinical outcome in Group A compared to Group C patients [OR(95%CI): 7.50 (1.46 – 38.70); P = 0.04]. Moreover, group C patients experienced higher levels of pain at the end of follow-up period [median Izbicki Score 0 (group A) vs. 0 (group B) vs. 6 (group C), P = 0.03]. Conclusions In patients with painful CP and distal MPD obstruction, treatment with a single stent is associated with better clinical outcome compared to treatment with exclusively two stents during the stenting period.
Cases and Techniques Library (CTL) E24Musala Carmen et al. Boerhaave syndrome treatment with an over-the-scope clip … Endoscopy 2015; 47: E24-E25
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