Objective Endoscopic pyloromyotomy (G-POEM) is a minimally invasive treatment option with promising uncontrolled outcome results in patients with gastroparesis.
Design 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.
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 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.
Conclusion 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.
Trial registration number NCT03356067; ClinicalTrials.gov.
- GASTRIC EMPTYING
Data availability statement
Data are available upon reasonable request.
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Contributors JMartinek: study concept and study design, patient’s recruitment, performing all G-POEM procedures, follow-up endoscopies, drafting the manuscript; the guarantor. RH: study design, data collection, assisting the procedures, follow-up endoscopies, drafting the manuscript. JMares: statistical analysis, study design, drafting the manuscript. ZV: patient’s recruitment and selection, measurement and analysis of pyloric distensibility measurement, follow-up endoscopies, critical review of the manuscript. JS: follow-up endoscopies, critical review of the manuscript. EK: anaesthesia during procedures, analysis of AEs, critical review of the manuscript. MB: gastric emptying studies—analysis and critical review of the manuscript. DP: Endoflip measurement and analysis, study design. SA: critical review of the manuscript, advisor. JT: study concept, study design, data analysis and interpretation, critical review of the manuscript.
Funding The work was supported by a Grant 17-28797A from the Czech Ministry of Health.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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