Endoscopic pyloromyotomy for the treatment of severe and refractory gastroparesis: a pilot, randomised, sham-controlled trial
Language English Country Great Britain, England Media print-electronic
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
35470243
PubMed Central
PMC9554080
DOI
10.1136/gutjnl-2022-326904
PII: gutjnl-2022-326904
Knihovny.cz E-resources
- Keywords
- GASTRIC EMPTYING, GASTROPARESIS,
- MeSH
- Gastroparesis * etiology surgery MeSH
- Gastroscopy methods MeSH
- Humans MeSH
- Prospective Studies MeSH
- Pyloromyotomy * adverse effects methods MeSH
- Gastric Emptying MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
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.
Clinical and Experimental Medicine University of Leuven Leuven Belgium
Department of Internal Medicine University Hospital Trnava Trnava Slovakia
Department of Nuclear Medicine Institute of Clinical and Experimental Medicine Praha Czech Republic
Division of Gastroenterology and Hepatology University Hospital Zürich Zürich Switzerland
Division of Gastroenterology University of Miami Miller School of Medicine Miami Florida USA
Institute of Physiology Charles University Prague Prague Czech Republic
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ClinicalTrials.gov
NCT03356067
