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

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F22%3A00082666" target="_blank" >RIV/00023001:_____/22:00082666 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/22:10467316

Result on the web

<a href="https://gut.bmj.com/content/early/2022/04/24/gutjnl-2022-326904" target="_blank" >https://gut.bmj.com/content/early/2022/04/24/gutjnl-2022-326904</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1136/gutjnl-2022-326904" target="_blank" >10.1136/gutjnl-2022-326904</a>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30219 - Gastroenterology and hepatology

Project

<a href="/en/project/NV17-28797A" target="_blank" >NV17-28797A: G-POEM in patients with refractory idiopathic and diabetic gastroparesis – a controlled randomized „sham“ study</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

Gut

ISSN

0017-5749

e-ISSN

1468-3288

Volume of the periodical

71

Issue of the periodical within the volume

11

Country of publishing house

GB - UNITED KINGDOM

Number of pages

9

Pages from-to

2170-2178

UT code for WoS article

000788204100001

EID of the result in the Scopus database

2-s2.0-85130781618