Peroral endoscopic myotomy: anterior versus posterior approach: a randomized single-blinded clinical trial.
Adult
Aged
Deglutition Disorders
/ physiopathology
Endoscopy, Digestive System
/ methods
Esophageal Achalasia
/ physiopathology
Esophageal pH Monitoring
Female
Gastroesophageal Reflux
/ drug therapy
Humans
Length of Stay
/ statistics & numerical data
Male
Manometry
Middle Aged
Myotomy
/ methods
Postoperative Complications
/ drug therapy
Proton Pump Inhibitors
/ therapeutic use
Quality of Life
Single-Blind Method
Treatment Outcome
Journal
Gastrointestinal endoscopy
ISSN: 1097-6779
Titre abrégé: Gastrointest Endosc
Pays: United States
ID NLM: 0010505
Informations de publication
Date de publication:
02 2020
02 2020
Historique:
received:
25
01
2019
accepted:
24
07
2019
pubmed:
14
8
2019
medline:
26
1
2021
entrez:
14
8
2019
Statut:
ppublish
Résumé
Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM. This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year. One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups. Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).
Sections du résumé
BACKGROUND AND AIMS
Peroral endoscopic myotomy (POEM) has become the mainstay for the treatment of achalasia at many institutions around the world since its inception in 2008. POEM can be performed using either the anterior or posterior approach. The primary aim of this study was to compare the efficacy of the anterior and posterior approaches at 1 year after POEM.
METHODS
This is a single-blinded, randomized, noninferiority international clinical trial. Eligible participants were adult patients with a confirmed diagnosis of achalasia via high-resolution esophageal manometry. Patients were randomly allocated with a 1:1 ratio to receive POEM with anterior or posterior approach. The primary aim was to compare the rate of clinical success (Eckardt score <3) of anterior and posterior approaches at 1 year.
RESULTS
One hundred fifty patients were randomized to receive either anterior (n = 73) or posterior (n = 77) POEM. One hundred forty-eight patients received the POEM treatment, and 138 patients completed the 1-year follow-up and were included in the primary efficacy analysis. Technical success was achieved in 71 patients (97.3%) in the anterior group versus 77 patients (100%) in the posterior group (P = .23). The median (interquartile range) length of hospital stay after the procedure was 2 (1-3) days for both groups. Adverse events occurred in 15 patients (10%), 8 patients (11%) in the anterior group and 7 patients (9%) in the posterior group (P = .703). Clinical success was achieved in 90% of patients in the anterior group and 89% of patients in the posterior group. Abnormal esophageal acid exposure was detected in 29 of 59 patients (49%) and 25 of 60 patients (42%) in the anterior and posterior groups, respectively (P = .67). GERD questionnaire scores were also not significantly different between the study groups. In both groups, quality of life improved after POEM for all 36-Item Short-Form Health Survey measures and was similar between both groups.
CONCLUSIONS
Posterior myotomy during POEM was not inferior to anterior myotomy in terms of efficacy and safety in the treatment of patients with achalasia. (Clinical trial registration number: NCT02454335.).
Identifiants
pubmed: 31408652
pii: S0016-5107(19)32116-9
doi: 10.1016/j.gie.2019.07.034
pii:
doi:
Substances chimiques
Proton Pump Inhibitors
0
Banques de données
ClinicalTrials.gov
['NCT02454335']
Types de publication
Comparative Study
Equivalence Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
288-297.e7Commentaires et corrections
Type : CommentIn
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.