Prospective cohort study demonstrates significant symptom relief after pyloric dilatation in DGE patients, indicating effective treatment evaluation.
Summary Objectives Delayed gastric emptying (DGE) following esophago-gastrectomy significantly affects quality of life. There is no standardized measurement tool for the impact of treatment for DGE on patient symptoms. This study aimed to assess the use of a novel symptom response questionnaire, registered with the European Organization for Research and Treatment of Cancer (EORTC), to objectively evaluate treatment efficacy in patients with DGE following endoscopic pyloric dilatation (EPD). Methods A prospective cohort study was conducted over a 6-month period, including consecutive patients with a history of esophageal cancer resection undergoing EPD for DGE. Clinical symptoms and endoscopic findings determined the diagnosis of DGE and thus patient suitability for EPD. The procedure involved the use of a water-based balloon catheter (20 mm diameter) inflated for 2 minutes under direct endoscopic vision. A symptom response questionnaire, developed from selected EORTC items, was administered via telephone consultation at 2- and 4-weeks post-intervention to assess symptom frequency, severity, overall health, and treatment satisfaction. Statistical analyses used descriptive statistics, the Wilcoxon signed-rank test for within-subject comparisons, and the Mann–Whitney U test for between-group differences, with a significance level set at P < 0.05. Results Fifty-one patients were enrolled, with 50 completing the follow-up. After EPD, a significant reduction in the frequency of the main symptom (assessed over the prior 7 days on a 4-point Likert scale; baseline median score 4 [interquartile ranges (IQR) = 3–4], reduced to 2 [IQR = 1–3] at 2 weeks and sustained at 4 weeks, P < 0.01) and its severity (scored over the prior 7 days on a 0–10 scale; baseline median score 7 [IQR = 6–8], reduced to 2.5 [IQR = 2–3] at 2 weeks and 3 [IQR = 1–4] at 4 weeks, P < 0.01) was observed. Symptoms assessed included dysphagia, regurgitation, reflux, nausea, early satiety, and bloating. At 4 weeks, patients reported a significant improvement in overall health, with the median health scale score increasing from 5 (IQR = 2–8) to 7 (IQR = 5–8) (P < 0.01). The level of satisfaction with the questionnaire process was rated at a median score of 7 (IQR = 7–7) for both happiness and ease of completion on a Likert scale from 1 (lowest) to 7 (highest). Seven patients (14%) required subsequent dilatations within 3 months. These were successfully identified at the 4-week questionnaire, demonstrating a significant increase in symptom frequency and severity compared to the group not requiring further EPD (P < 0.01). Conclusion The symptom response questionnaire effectively quantified symptom improvement following EPD for DGE, offering a novel, reproduceable approach to evaluate treatment outcomes. The findings support the procedure’s efficacy, with most patients reporting significant relief. Additionally, the questionnaire facilitated the identification of non-responders, guiding timely interventions.
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Chevallay et al. (2025) studied this question.
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