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: 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: 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: 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 investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis. METHODS: A total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score. RESULTS: The mean decreases in the total symptom score at 4 weeks were estimated to be −18.1±13.8 in the combination therapy group and −15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were −8.4±6.6 in the combination therapy group and −6.8±5.9 in the monotherapy group (p=0.009). CONCLUSIONS: Over a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.
Esomeprazole* ; Esophagitis, Peptic* ; Heartburn ; Humans

BACKGROUND/AIMS: To investigate the effects of esomeprazole and rebamipide combination therapy on symptomatic improvement in patients with reflux esophagitis. METHODS: A total of 501 patients with reflux esophagitis were randomized into one of the following two treatment regimens: 40 mg esomeprazole plus 300 mg rebamipide daily (combination therapy group) or 40 mg esomeprazole daily (monotherapy group). We used a symptom questionnaire that evaluated heartburn, acid regurgitation, and four upper gastrointestinal symptoms. The primary efficacy end point was the mean decrease in the total symptom score. RESULTS: The mean decreases in the total symptom score at 4 weeks were estimated to be −18.1±13.8 in the combination therapy group and −15.1±11.9 in the monotherapy group (p=0.011). Changes in reflux symptoms from baseline after 4 weeks of treatment were −8.4±6.6 in the combination therapy group and −6.8±5.9 in the monotherapy group (p=0.009). CONCLUSIONS: Over a 4-week treatment course, esomeprazole and rebamipide combination therapy was more effective in decreasing the symptoms of reflux esophagitis than esomeprazole monotherapy.
Esomeprazole* ; Esophagitis, Peptic* ; Heartburn ; Humans