Gastric per-oral endoscopic myotomy (G-POEM) is safe and modestly effective for treating patients with refractory gastroparesis, according to a study in Gut.
Investigators enrolled 80 patients (mean age, 49.3±14.9 years; 57 [71.3%] female) with refractory gastroparesis from November 2015 to November 2018 in the international, multicenter, prospective study. All patients had successful G-POEM, and 5 patients did not complete the 12-month follow-up. The primary end point was clinical success at 12 months, defined as having at least a 1-score decrease on the Gastroparesis Cardinal Symptom Index (GCSI) and a ≥25% decrease in 2 subscales 12 months after G-POEM.
Of the 75 patients who completed the follow-up, 42 (56%; 95% CI, 44.8 to 66.7) achieved clinical success at 12 months. Clinical success rates were 57.5% (95% CI, 46.1 to 68.2) at 1 month, 61.5% (95% CI, 49.4 to 72.4) at 3 months, and 60.3% (95% CI, 48 to 71.5) at 6 months after G-POEM.
Participants’ average GCSI scores decreased from 2.8±1.1 (mean±SD) at baseline to 1.6±1.1 at 1 month (P <.001) and from 1.5±1.2 at 12 months (P <.001).
Significant improvement was observed in a majority of the quality of life aspects at 12 months and over time.
In patients with gastric emptying scintigraphy (GES) improvement, the clinical success rate at 3 months was 75.8% (25 of 33 cases) compared with 38.9% (7 of 18 cases) in participants who did not have GES improvement (P =.015).
A total of 5 adverse events (AEs) (6.2%) were reported, all rated as mild and procedure related. Among the AEs, 3 patients had symptomatic capnoperitoneum, 1 patient had mucosotomy, and 1 had thermal mucosal injury.
Multivariable analysis demonstrated that higher baseline GCSI scores greater than 2.6 (odds ratio [OR], 3.23; P =.04) and baseline gastric retention greater than 20% at 4 hours (OR, 3.65; P =.029) were independent predictors of clinical success at 12 months.
The study has several limitations noted by the investigators. The lack of a placebo control group prevented estimation of the absolute clinical success rate and sham/placebo effect of G-POEM. Additionally, gastric emptying was not evaluated at 12 months, concurrent with the primary end point.
“Our results show that G-POEM is a modestly effective, minimally invasive procedure that provides patients with a durable outcome in terms of symptom improvement and quality of life, suggesting that G-POEM may lead to reduction in healthcare cost and burden of refractory gastroparesis,” the study authors commented.
Disclosures: Some of the authors reported affiliations with medical technology and pharmaceutical companies. Please see the original reference for a full list of disclosures.
Vosoughi K, Ichkhanian Y, Benias P, et al. Gastric per-oral endoscopic myotomy (G-POEM) for refractory gastroparesis: results from an international prospective trial. Gut. Published online March 19, 2021. doi: 10.1136/gutjnl-2020-322756