Division of Gastroenterology and Hepatology, Johns Hopkins Medicine, Baltimore, Maryland, USA.
Department of Medicine, Henry Ford Health System, Detroit, Michigan, USA.
Gut. 2022 Jan;71(1):25-33. doi: 10.1136/gutjnl-2020-322756. Epub 2021 Mar 19.
Although gastric per-oral endoscopic myotomy (G-POEM) is considered a promising technique for the management of refractory gastroparesis, high-quality evidence is limited. We prospectively investigated the efficacy and safety of G-POEM in unselected patients with refractory gastroparesis.
In five tertiary centres, patients with symptomatic gastroparesis refractory to standard medical therapy and confirmed by impaired gastric emptying were included. The primary endpoint was clinical success, defined as at least one score decrease in Gastroparesis Cardinal Symptom Index (GCSI) with ≥25% decrease in two subscales, at 12 months. GCSI Score and subscales, adverse events (AEs) and 36-Item Short Form questionnaire of quality of life were evaluated at baseline and 1, 3, 6 and 12 months after G-POEM. Gastric emptying study was performed before and 3 months after the procedure.
Of 80 enrolled patients, 75 patients (94%) completed 12-month follow-up. Clinical success at 12 months was 56% (95% CI, 44.8 to 66.7). GCSI Score (including subscales) improved moderately after G-POEM (p<0.05). In a regression model, a baseline GCSI Score >2.6 (OR=3.23, p=0.04) and baseline gastric retention >20% at 4 hours (OR=3.65, p=0.03) were independent predictors of clinical success at 12 months, as was early response to G-POEM at 1 month after therapy (OR 8.75, p<0.001). Mild procedure-related AEs occurred in 5 (6%) patients.
G-POEM is a safe procedure, but showed only modest overall effectiveness in the treatment of refractory gastroparesis. Further studies are required to identify the best candidates for G-POEM; unselective use of this procedure should be discouraged.
ClinicalTrials.gov Registry NCT02732821.
尽管经口内镜下胃肌切开术（G-POEM）被认为是治疗难治性胃轻瘫的一种有前途的技术，但高质量的证据有限。我们前瞻性地研究了 G-POEM 在未经选择的难治性胃轻瘫患者中的疗效和安全性。
在五个三级中心，纳入了对标准药物治疗有反应且胃排空受损的症状性难治性胃轻瘫患者。主要终点是临床成功，定义为 12 个月时 GCSI 至少下降 1 分，且两个亚量表至少下降 25%。GCSI 评分和亚量表、不良事件（AE）和 36 项简明健康调查问卷的生活质量在基线和 G-POEM 后 1、3、6 和 12 个月进行评估。胃排空研究在术前和术后 3 个月进行。
80 名入组患者中，75 名（94%）完成了 12 个月的随访。12 个月时的临床成功率为 56%（95%CI，44.8 至 66.7）。G-POEM 后 GCSI 评分（包括亚量表）中度改善（p<0.05）。在回归模型中，基线 GCSI 评分>2.6（OR=3.23，p=0.04）和基线胃潴留>4 小时 20%（OR=3.65，p=0.03）是 12 个月时临床成功的独立预测因素，治疗后 1 个月对 G-POEM 的早期反应（OR 8.75，p<0.001）也是独立预测因素。5 名（6%）患者发生轻微与操作相关的 AE。
G-POEM 是一种安全的手术，但在治疗难治性胃轻瘫方面总体效果仅为中等。需要进一步的研究来确定 G-POEM 的最佳候选人群；应劝阻对此类患者进行无选择的治疗。
ClinicalTrials.gov 注册号 NCT02732821。
