Endoscopic or surgical myotomy in patients with idiopathic achalasia

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00023001%3A_____%2F19%3A00078661" target="_blank" >RIV/00023001:_____/19:00078661 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/19:10403034 RIV/00064203:_____/19:10403034

Result on the web

<a href="https://www.nejm.org/doi/pdf/10.1056/NEJMoa1905380?articleTools=true" target="_blank" >https://www.nejm.org/doi/pdf/10.1056/NEJMoa1905380?articleTools=true</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/NEJMoa1905380" target="_blank" >10.1056/NEJMoa1905380</a>

Result language

angličtina

Original language name

Endoscopic or surgical myotomy in patients with idiopathic achalasia

Original language description

BACKGROUND: Pneumatic dilation and laparoscopic Heller&apos;s myotomy (LHM) are established treatments for idiopathic achalasia. Peroral endoscopic myotomy (POEM) is a less invasive therapy with promising early study results. METHODS: In a multicenter, randomized trial, we compared POEM with LHM plus Dor&apos;s fundoplication in patients with symptomatic achalasia. The primary end point was clinical success, defined as an Eckardt symptom score of 3 or less (range, 0 to 12, with higher scores indicating more severe symptoms of achalasia) without the use of additional treatments, at the 2-year follow-up; a noninferiority margin of -12.5 percentage points was used in the primary analysis. Secondary end points included adverse events, esophageal function, Gastrointestinal Quality of Life Index score (range, 0 to 144, with higher scores indicating better function), and gastroesophageal reflux. RESULTS: A total of 221 patients were randomly assigned to undergo either POEM (112 patients) or LHM plus Dor&apos;s fundoplication (109 patients). Clinical success at the 2-year follow-up was observed in 83.0% of patients in the POEM group and 81.7% of patients in the LHM group (difference, 1.4 percentage points; 95% confidence interval [CI], -8.7 to 11.4; P = 0.007 for noninferiority). Serious adverse events occurred in 2.7% of patients in the POEM group and 7.3% of patients in the LHM group. Improvement in esophageal function from baseline to 24 months, as assessed by measurement of the integrated relaxation pressure of the lower esophageal sphincter, did not differ significantly between the treatment groups (difference, -0.75 mm Hg; 95% CI, -2.26 to 0.76), nor did improvement in the score on the Gastrointestinal Quality of Life Index (difference, 0.14 points; 95% CI, -4.01 to 4.28). At 3 months, 57% of patients in the POEM group and 20% of patients in the LHM group had reflux esophagitis, as assessed by endoscopy; at 24 months, the corresponding percentages were 44% and 29%. CONCLUSIONS: In this randomized trial, POEM was noninferior to LHM plus Dor&apos;s fundoplication in controlling symptoms of achalasia at 2 years. Gastroesophageal reflux was more common among patients who underwent POEM than among those who underwent LHM. (Funded by the European Clinical Research Infrastructure Network and others; ClinicalTrials.gov number, NCT01601678.). Copyright © 2019 Massachusetts Medical Society.

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

—

Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2019

Confidentiality

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

Name of the periodical

New England journal of medicine

ISSN

0028-4793

e-ISSN

—

Volume of the periodical

381

Issue of the periodical within the volume

23

Country of publishing house

US - UNITED STATES

Number of pages

11

Pages from-to

2219-2229

UT code for WoS article

000505219800007

EID of the result in the Scopus database

2-s2.0-85076280539