Department of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Praha, Czech Republic
Department of Internal Medicine, University Hospital Trnava, Trnava, Slovakia.
Gut. 2022 Nov;71(11):2170-2178. doi: 10.1136/gutjnl-2022-326904. Epub 2022 Apr 25.
Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.
In this prospective randomised trial, we compared G-POEM with a sham procedure in patients with severe gastroparesis. The primary outcome was the proportion of patients with treatment success (defined as a decrease in the Gastroparesis Cardinal Symptom Index (GCSI) by at least 50%) at 6 months. Patients randomised to the sham group with persistent symptoms were offered cross-over G-POEM.
The enrolment was stopped after the interim analysis by the Data and Safety Monitoring Board prior to reaching the planned sample of 86 patients. A total of 41 patients (17 diabetic, 13 postsurgical, 11 idiopathic; 46% male) were randomised (21 G-POEM, 20-sham). Treatment success rate was 71% (95% CI 50 to 86) after G-POEM versus 22% (8-47) after sham (p=0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI 56 to 98), 50% (18-82) and 67% (30-90) after G-POEM; the corresponding rates in the sham group were 17% (3-57), 29% (7-67) and 20% (3-67).Median gastric retention at 4 hours decreased from 22% (95% CI 17 to 31) to 12% (5-22) after G-POEM and did not change after sham: 26% (18-39) versus 24% (11-35). Twelve patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.
In severe gastroparesis, G-POEM is superior to a sham procedure for improving both symptoms and gastric emptying 6 months after the procedure. These results are not entirely conclusive in patients with idiopathic and postsurgical aetiologies.
NCT03356067; ClinicalTrials.gov.
内镜幽门肌切开术（G-POEM）是一种微创治疗选择，对于胃轻瘫患者具有有前景的不可控结果。
在这项前瞻性随机试验中，我们比较了 G-POEM 与严重胃轻瘫患者的假手术。主要结局是治疗成功的患者比例（定义为胃轻瘫 Cardinal 症状指数（GCSI）至少降低 50%）在 6 个月时。随机分配到假手术组且持续存在症状的患者接受交叉 G-POEM。
数据和安全监测委员会在达到计划的 86 例患者样本之前，在中期分析时停止了入组。共有 41 例患者（17 例糖尿病，13 例手术后，11 例特发性；46%为男性）被随机分配（21 例 G-POEM，20 例假手术）。G-POEM 后的治疗成功率为 71%（95%CI 50 至 86），而假手术后为 22%（8 至 47）（p=0.005）。糖尿病、手术后和特发性胃轻瘫患者的 G-POEM 治疗成功率分别为 89%（95%CI 56 至 98）、50%（18 至 82）和 67%（30 至 90）；假手术组的相应率分别为 17%（3 至 57）、29%（7 至 67）和 20%（3 至 67）。4 小时时胃潴留中位数从 22%（95%CI 17 至 31）降低至 G-POEM 后的 12%（5 至 22），而假手术后未发生变化：26%（18 至 39）与 24%（11 至 35）。12 例患者交叉至 G-POEM，其中 9 例（75%）治疗成功。
在严重胃轻瘫中，G-POEM 优于假手术，可改善术后 6 个月时的症状和胃排空。对于特发性和手术后病因的患者，这些结果并不完全具有结论性。
NCT03356067；ClinicalTrials.gov。
