Esophagus to Small Intestine

Gut. 2022;71(11):2170–8

Martinek J, Hustak R, Mares J, Vackova Z, Spicak J, Kieslichova E, Buncova M, Pohl D, Amin S, Tack J

Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: A pilot, randomized, sham-controlled trial


Objective: Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.
Design: In this prospective randomized trial, the authors 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 randomized to the sham group with persistent symptoms were offered cross-over G-POEM.
Results: 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 randomized (21 G-POEM, 20 sham). Treatment success rate was 71% (95% confidence interval [CI]: 50–86) after G-POEM versus 22% (95% CI: 8–47) after sham (p = 0.005). Treatment success in patients with diabetic, postsurgical and idiopathic gastroparesis was 89% (95% CI: 56–98), 50% (95% CI: 18–82) and 67% (95% CI: 30–90) after G-POEM; the corresponding rates in the sham group were 17% (95% CI: 3–57), 29% (95% CI: 7–67) and 20% (95% CI: 3–67). Median gastric retention at 4 hours decreased from 22% (95% CI: 17–31) to 12% (95% CI: 5–22) after G-POEM and did not change after sham: 26% (95% CI: 18–39) versus 24% (95% CI: 11–35). 12 patients crossed over to G-POEM with 9 of them (75%) achieving treatment success.

Conclusion: In severe gastroparesis, endoscopic pyloromyotomy 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 etiologies.

Prof. Dr. J. Martinek, Department of Hepatogastroenterology, Institute of Clinical and Experimental Medicine, Prague, Czech Republic,
E-Mail: jan.martinek@volny.cz

DOI: 10.1136/gutjnl-2022-326904

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