Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial
Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial
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DOI：
10.1136/gutjnl-2020-322756
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发表时间：
2021-03-19
期刊：
影响因子：
24.5
通讯作者：
Khashab, Mouen
中科院分区：
文献类型：
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作者：
Vosoughi, Kia;Ichkhanian, Yervant;Khashab, Mouen
目的虽然胃经口内镜肌切开术（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在难治性胃轻瘫患者的疗效和安全性，设计在五个三级中心，症状性胃轻瘫难治性标准药物治疗和确认受损胃排空的患者。主要终点是临床成功，定义为12个月时胃轻瘫主要症状指数（GCSI）至少降低1分，两个分量表降低≥ 25%。在基线和G-POEM后1、3、6和12个月评估GCSI评分和子量表、不良事件（AE）和生活质量36项简表问卷。结果80例患者中，75例（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 - 66.7）。G-POEM后GCSI评分（包括分量表）中度改善（p2.6（OR=3.23，p=0.04）和4小时基线胃潴留>20%（OR=3.65，p=0.03）是12个月临床成功的独立预测因素，治疗后1个月G-POEM的早期反应也是如此（OR 8.75，p = 0.04）。
Objective 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.Design 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.Results 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 (p2.6 (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