Tracheoesophageal fistulas (TEFs) have traditionally been managed surgically, but the endoscopic approach is widely performed as a less invasive alternative. Different closure techniques have been proposed with inconsistent results. An over-the-scope clip (OTSC) appears to be a reasonable option, but long-term results have not been well defined. We report the long-term outcomes of a complex case of successful closure of a benign refractory TEF using an OTSC after failed surgical management and esophageal stent placement.

BACKGROUND/AIMS: To compare the efficacy and safety of prucalopride, a novel selective high-affinity 5-hydroxytryptamine type 4 receptor agonist, versus placebo, in Asian and non-Asian women with chronic constipation (CC). METHODS: Data of patients with CC, receiving once-daily prucalopride 2-mg or placebo for 12-weeks, were pooled from 4 double-blind, randomized, phase-III trials (NCT00488137, NCT00483886, NCT00485940 and NCT01116206). The efficacy endpoints were: average of > or = 3 spontaneous complete bowel movements (SCBMs)/week; average increases of > or = 1 SCBMs/week; and change from baseline in each CC-associated symptom scores (bloating, abdominal pain, hard stool and straining). RESULTS: Overall, 1,596 women (Asian [26.6%], non-Asian [73.4%]) were included in this analysis. Significantly more patients in the prucalopride group versus placebo experienced an average of > or = 3 SCBMs/week in Asian (34% vs. 11%, P < 0.001) and non-Asian (24.6% vs. 10.6%, P < 0.001) subgroups. The number of patients reporting an increase of > or = 1 SCBMs/week from baseline was significantly higher in the prucalopride group versus placebo among both Asian (57.4% vs. 28.3%, P < 0.001) and non-Asian (45.3% vs. 24.0%, P < 0.001) subgroups. The difference between the subgroups was not statistically significant. Prucalopride significantly reduced the symptom scores for bloating, hard stool, and straining in both subgroups. CONCLUSIONS: Prucalopride 2-mg once-daily treatment over 12-weeks was more efficacious than placebo in promoting SCBMs and improvement of CC-associated symptoms in Asian and non-Asian women, and was found to be safe and well-tolerated. There were numeric differences between Asian and non-Asian patients on efficacy and treatment emergent adverse events, which may be partially due to the overlap with functional gastrointestinal disorders in non-Asian patients.
Abdominal Pain ; Asian Continental Ancestry Group* ; Constipation* ; Female ; Gastrointestinal Diseases ; Humans ; Serotonin ; Serotonin 5-HT4 Receptor Agonists

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to experience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. CONCLUSIONS: Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

Background/Aims: Achalasia is a rare esophageal motility disease, for which peroral endoscopic myotomy (POEM) has emerged as a promising treatment option; however, recurrence remains a challenge. Timed barium esophagography (TBE) is a useful diagnostic tool and potential outcome predictor of achalasia. This study aimed to determine predictive tools for recurrence after POEM. Methods: This retrospective study enrolled achalasia patients who underwent POEM between January 2015 and December 2021. Patients were categorized into two groups using the 1-month post-POEM Eckardt scores and TBE: the discordant group (Eckardt score improved >50%, TBE decreased <50%) and the concordant group (both Eckardt score and TBE improved >50%). Recurrence was defined as a reincrease in the Eckardt score to more than three during follow-up. Results: Complete medical records were available in 30 patients who underwent POEM. Seventeen patients (56.7%) were classified into the discordant group, while 13 patients (43.3%) were in the concordant group. The overall recurrence rate was 11.9% at 1-year, increasing to 23.8% during the extended follow-up. The discordant group had a 6.87 fold higher recurrence rate than the concordant group (52.9% vs. 7.7%, p=0.017). Conclusions These results strongly suggest that combining the Eckardt score with TBE can effectively predict recurrent achalasia after POEM. Patients in the discordant group had an elevated risk.

Background/Aims: Achalasia is a rare esophageal motility disease, for which peroral endoscopic myotomy (POEM) has emerged as a promising treatment option; however, recurrence remains a challenge. Timed barium esophagography (TBE) is a useful diagnostic tool and potential outcome predictor of achalasia. This study aimed to determine predictive tools for recurrence after POEM. Methods: This retrospective study enrolled achalasia patients who underwent POEM between January 2015 and December 2021. Patients were categorized into two groups using the 1-month post-POEM Eckardt scores and TBE: the discordant group (Eckardt score improved >50%, TBE decreased <50%) and the concordant group (both Eckardt score and TBE improved >50%). Recurrence was defined as a reincrease in the Eckardt score to more than three during follow-up. Results: Complete medical records were available in 30 patients who underwent POEM. Seventeen patients (56.7%) were classified into the discordant group, while 13 patients (43.3%) were in the concordant group. The overall recurrence rate was 11.9% at 1-year, increasing to 23.8% during the extended follow-up. The discordant group had a 6.87 fold higher recurrence rate than the concordant group (52.9% vs. 7.7%, p=0.017). Conclusions These results strongly suggest that combining the Eckardt score with TBE can effectively predict recurrent achalasia after POEM. Patients in the discordant group had an elevated risk.

Background/Aims: Achalasia is a rare esophageal motility disease, for which peroral endoscopic myotomy (POEM) has emerged as a promising treatment option; however, recurrence remains a challenge. Timed barium esophagography (TBE) is a useful diagnostic tool and potential outcome predictor of achalasia. This study aimed to determine predictive tools for recurrence after POEM. Methods: This retrospective study enrolled achalasia patients who underwent POEM between January 2015 and December 2021. Patients were categorized into two groups using the 1-month post-POEM Eckardt scores and TBE: the discordant group (Eckardt score improved >50%, TBE decreased <50%) and the concordant group (both Eckardt score and TBE improved >50%). Recurrence was defined as a reincrease in the Eckardt score to more than three during follow-up. Results: Complete medical records were available in 30 patients who underwent POEM. Seventeen patients (56.7%) were classified into the discordant group, while 13 patients (43.3%) were in the concordant group. The overall recurrence rate was 11.9% at 1-year, increasing to 23.8% during the extended follow-up. The discordant group had a 6.87 fold higher recurrence rate than the concordant group (52.9% vs. 7.7%, p=0.017). Conclusions These results strongly suggest that combining the Eckardt score with TBE can effectively predict recurrent achalasia after POEM. Patients in the discordant group had an elevated risk.

Background/Aims: Achalasia is a rare esophageal motility disease, for which peroral endoscopic myotomy (POEM) has emerged as a promising treatment option; however, recurrence remains a challenge. Timed barium esophagography (TBE) is a useful diagnostic tool and potential outcome predictor of achalasia. This study aimed to determine predictive tools for recurrence after POEM. Methods: This retrospective study enrolled achalasia patients who underwent POEM between January 2015 and December 2021. Patients were categorized into two groups using the 1-month post-POEM Eckardt scores and TBE: the discordant group (Eckardt score improved >50%, TBE decreased <50%) and the concordant group (both Eckardt score and TBE improved >50%). Recurrence was defined as a reincrease in the Eckardt score to more than three during follow-up. Results: Complete medical records were available in 30 patients who underwent POEM. Seventeen patients (56.7%) were classified into the discordant group, while 13 patients (43.3%) were in the concordant group. The overall recurrence rate was 11.9% at 1-year, increasing to 23.8% during the extended follow-up. The discordant group had a 6.87 fold higher recurrence rate than the concordant group (52.9% vs. 7.7%, p=0.017). Conclusions These results strongly suggest that combining the Eckardt score with TBE can effectively predict recurrent achalasia after POEM. Patients in the discordant group had an elevated risk.

BACKGROUND/AIMS: To report gastric emptying scintigraphy, normal values should be established for a specific protocol. The aim of this study was to provide normal gastric emptying values and determine factors affecting gastric emptying using Asian rice-based meal in healthy volunteers. METHODS: One hundred and ninety-two healthy volunteers were included at 7 tertiary care centers across Thailand. Gastric emptying scintigraphy was acquired in 45 degree left anterior oblique view immediately after ingestion of a 267 kcal steamed-rice with technetium-99m labeled-microwaved egg meal with 100 mL water for up to 4 hours. RESULTS: One hundred and eighty-nine volunteers (99 females, age 43 +/- 14 years) completed the study. The medians (5-95th percentiles) of lag time, gastric emptying half time (GE T1/2) and percent gastric retentions at 2 and 4 hours for all volunteers were 18.6 (0.5-39.1) minutes, 68.7 (45.1-107.8) minutes, 16.3% (2.7-49.8%) and 1.1% (0.2-8.8%), respectively. Female volunteers had significantly slower gastric emptying compared to male (GE T1/2, 74 [48-115] minutes vs. 63 (41-96) minutes; P < 0.05). Female volunteers who were in luteal phase of menstrual cycle had significantly slower gastric emptying compared to those in follicular phase or menopausal status (GE T1/2, 85 [66-102] mintes vs. 69 [50-120] minutes or 72 [47-109] minutes, P < 0.05). All of smoking volunteers were male. Smoker male volunteers had significantly faster gastric emptying compared to non-smoker males (GE T1/2, 56 [44-80] minutes vs. 67 [44-100] minutes, P < 0.05). Age, body mass index and alcohol consumption habits did not affect gastric emptying values. CONCLUSIONS: A steamed-rice with microwaved egg meal was well tolerated by healthy volunteers. Gender, menstrual status and smoking status were found to affect solid gastric emptying.
Alcohol Drinking ; Asian Continental Ancestry Group ; Body Mass Index ; Eating ; Female ; Follicular Phase ; Gastric Emptying* ; Healthy Volunteers* ; Humans ; Luteal Phase ; Male ; Meals* ; Menstrual Cycle ; Mentha ; Ovum ; Radionuclide Imaging* ; Reference Values ; Smoke ; Smoking ; Tertiary Care Centers ; Thailand ; Volunteers ; Water

Although gastroesophageal reflux disease is not as common in Asia as in western countries, the prevalence has increased substantially during the past decade. Gastroesophageal reflux disease is associated with considerable reductions in subjective well-being and work productivity, as well as increased healthcare use. Proton pump inhibitors (PPIs) are currently the most effective treatment for gastroesophageal reflux disease. However, there are limitations associated with these drugs in terms of partial and non-response. Dexlansoprazole is the first PPI with a dual delayed release formulation designed to provide 2 separate releases of medication to extend the duration of effective plasma drug concentration. Dexlansoprazole has been shown to be effective for healing of erosive esophagitis, and to improve subjective well-being by controlling 24-hour symptoms. Dexlansoprazole has also been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing. Studies in healthy volunteers showed no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition, with no dose adjustment of clopidogrel necessary when coprescribed. This review discusses the role of the new generation PPI, dexlansoprazole, in the treatment of gastroesophageal reflux disease in Asia.
Asia* ; Blood Platelets ; Delayed-Action Preparations ; Delivery of Health Care ; Dexlansoprazole* ; Efficiency ; Esophagitis ; Gastroesophageal Reflux* ; Healthy Volunteers ; Plasma ; Prevalence ; Proton Pump Inhibitors ; Proton Pumps* ; Protons*