Risk Factors for Adverse Events in Patients with Chronic Constipation Following Lubiprostone Administration.

INTRODUCTION: Lubiprostone is an effective treatment of chronic constipation (CC). However, as with other stimulant or osmotic laxatives, adverse events (AEs) can make it difficult to continue treatment. This article investigates AE risk factors associated with lubiprostone. METHODS: We retrospectively analyzed all 1,338 Japanese patients with CC treated at our hospital from October 2013 to July 2017. All patients were diagnosed with constipation as defined by the Roma III criteria. Enrolled patients received lubiprostone orally (24 or 48 µg daily), after which we investigated the incidence of AEs. The causative factors for diarrhea and nausea, the most common AEs, were examined by the backward logistic regression model. RESULTS: Two hundred eight (15.5%) experienced at least 1 AE. No serious AEs were associated with the study drug. The AEs reported by >1% of patients overall were diarrhea (6.1%) and nausea (4.2%). We performed a multivariate logistic regression using a backward variable selection method to investigate AE risk factors. Factors associated with higher incidence of diarrhea were patient age of 65 years or more (odds ratio: [95% confidence interval]; p value) (2.09: [1.05-4.16]; 0.035). Factors associated with greater likelihood of nausea included female gender (1.99: [1.10-3.61]; 0.023), and the chief complaint was a patient complaining of abdominal pain and fullness (2.07: [1.01-4.22]; 0.046). CONCLUSIONS: Understanding AE risk factors can help avoid unnecessary AEs and promote more effective treatment.

Feasibility of the lidocaine injection method during esophageal endoscopic submucosal dissection.

BACKGROUND AND AIM: Esophageal endoscopic submucosal dissection (ESD) is often technically difficult due to intraoperative body movements. The level of sedation can be increased to suppress body movements, but this may not be successful in all cases. Using local analgesics for submucosal injection during ESD may aid in conscious sedation. This study evaluated the feasibility of the lidocaine injection method (LIM) during esophageal ESD. METHODS: Twenty-nine patients with superficial esophageal cancer were enrolled in this study at Osaka Saiseikai Nakatsu Hospital, and 1% lidocaine + 0.4% hyaluronate sodium was injected into the submucosa underneath the lesion during esophageal ESD. The main outcome was body movements that disturbed the procedure. RESULTS: Most patients were male (90%), with a median age of 70 years (interquartile range [IQR]: 66-75 years old), and the median lesion size was 17 mm (IQR: 12-21 mm). The median injection volume of lidocaine was 70 mg (IQR: 55-79 mg). All lesions were successfully removed en bloc. In all cases, there were no body movements that disturbed the procedure. Regarding adverse events of sedation, five patients (17%) had hypotension, four patients (14%) had bradycardia, and seven patients (24%) had hypoxemia during ESD. Convulsions or arrhythmia as adverse events associated with lidocaine were not observed. CONCLUSIONS: Esophageal ESD with LIM did not cause body movements that disturbed the procedure. LIM may help create a stable conscious sedation method for esophageal ESD.

Barrett's adenocarcinoma with esophageal varices successfully treated by endoscopic submucosal dissection with direct varices coagulation.

A 67-year-old Japanese man with alcoholic cirrhosis underwent esophagogastroduodenoscopy (EGD), which revealed a 15-mm elevated lesion on the esophagogastric junction (EGJ). Endoscopic findings suggested that the lesion was an intramucosal cancer present on the esophageal varices. The location of the lesion at EGJ caused difficulties in endoscopic injection sclerotherapy and endoscopic variceal ligation for esophageal varices before esophageal endoscopic submucosal dissection (ESD). Direct varices coagulation treatment was therefore selected during ESD. Coagulation of bared varices with hemostatic forceps after mucosal incision enabled performing ESD without serious bleeding. 2 months afterwards, the patient underwent EGD, with no esophageal varices or carcinoma recurrence. Direct varices coagulation was effective for ESD of Barrett adenocarcinoma with esophageal varices.

Endoscopic submucosal dissection for early gastric cancer on the lesser curvature in upper third of the stomach is a risk factor for postoperative delayed gastric emptying.

BACKGROUND: Advances in Endoscopic submucosal dissection (ESD) technology have established ESD for early gastric cancer as a safe and stable technique. However, ESD may induce delayed gastric emptying and the cause of food residue retention in the stomach after ESD is not clear. This study aimed to clarify risk factors for delayed gastric emptying with food retention after gastric ESD. METHODS: We retrospectively examined for food residue in the stomach 1 week after ESD was performed for early gastric carcinoma at Osaka Saiseikai Nakatsu Hospital from February 2008 to November 2016. RESULTS: Food residue was observed in 68 (6.1%) of 1114 patients who underwent gastric ESD. The percentage of lesions located on the lesser curvature of the upper third of the stomach was 45.6% (31/68) in the food residue group and 3.5% (37/1046) in the non-food residue group, which was significantly different (P < 0.01). Multivariate logistic regression analysis revealed that lesions on the lesser curvature of the upper third of the stomach (Odds ratio [OR] 23.31, 95% confidence interval [CI] 12.60-43.61, P < 0.01), post-ESD bleeding (OR 4.25, 95%CI 1.67-9.80, P < 0.01), submucosal invasion (OR 2.80, 95%CI 1.34-5.63, P < 0.01), and age over 80 years (OR 2.34, 95%CI 1.28-4.22, P < 0.01) were independent risk factors for food retention after gastric ESD. Of the 68 patients, 3 had food residue in the stomach on endoscopic examination for follow-up observation after the ESD ulcer had healed. CONCLUSIONS: Delayed gastric emptying with food retention after gastric ESD was associated with lesions located in the lesser curvature of the upper stomach, submucosal invasion of the lesion, age older than 80 years, and post-ESD bleeding, though it was temporary in most cases.

The Effects of Switching to Vonoprazan, a Novel Potassium-Competitive Acid Blocker, on Gastric Acidity and Reflux Patterns in Patients with Erosive Esophagitis Refractory to Proton Pump Inhibitors.

BACKGROUND/AIM: The effects of vonoprazan and proton pump inhibitors (PPIs) in patients with reflux esophagitis (RE) have not yet been compared using multichannel intraluminal impedance-pH (MII-pH). METHODS: A total of 8 patients with persistent gastric mucosal injury, despite completing an 8-week standard PPI therapy, were enrolled in the study. While they were on standard PPI therapy, the baseline values of reflux parameters, holding time ratio (HTR) of gastric pH >4, and esophageal pH <4 were obtained by using 24 h MII-pH monitoring. They were re-evaluated after discontinuation of the therapy and 4 weeks of subsequent treatment with vonoprazan 20 mg/day. RESULTS: The patients were found to be CYP2C19 extensive metabolizers and negative for Helicobacter pylori infection. In 7 patients (87.5%), the mucosal lesions had healed completely after vonoprazan therapy. A significant increase in gastric pH >4 HTR was observed, from 26.5 to 78.0% (p = 0.029). A reduction in esophageal pH <4 HTR was also observed but it was not statistically significant. Furthermore, acid clearance time and the total number of reflux events, including acid and proximal reflux events, were significantly reduced. CONCLUSION: Vonoprazan may be a better therapy for the treatment of patients with PPI-refractory RE.

A Comparative Study of a New Class of Gastric Acid Suppressant Agent Named Vonoparazan versus Esomeprazole for the Eradication of Helicobacter pylori.

BACKGROUND: Helicobacter pylori eradication rates have decreased worldwide. Gastric acid inhibition during treatment is important to eradicate these bacteria successfully. A new potassium-competitive acid blocker, vonoprazan (VPZ), has been shown to achieve high eradication rates in a previous randomized controlled trial. OBJECTIVE: To determine the efficacy of VPZ for H. pylori eradication. METHODS: A total of 874 patients were enrolled; 431 received esomeprazole (EPZ) and 443 received VPZ. First-line regimens contained clarithromycin (CAM) 200 mg b.i.d., amoxicillin 750 mg b.i.d., and either EPZ 20 mg b.i.d. or VPZ 20 mg b.i.d. for 7 days. Metronidazole 250 mg b.i.d. replaced CAM in the second-line regimens. The eradication of H. pylori was assessed by 13C-urea breath tests 4-8 weeks after each therapy. RESULTS: The overall first-line eradication rate was 79.9% (341/427) with EPZ vs. 86.3% (377/439) with VPZ (p = 0.019). The second-line eradication rate was 83.3% (45/51) with EPZ vs. 91.1% (41/45) with VPZ (p = 0.900). CONCLUSION: VPZ was significantly more effective than EPZ for first-line treatment. However, for second-line treatment, there was no significant difference between EPZ and VPZ.