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©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
Peroral endoscopic myotomy vs laparoscopic myotomy and partial fundoplication for esophageal achalasia: A single-center randomized controlled trial
Eduardo Turiani Hourneaux de Moura, José Jukemura, Igor Braga Ribeiro, Galileu Ferreira Ayala Farias, Aureo Augusto de Almeida Delgado, Lara Meireles Azeredo Coutinho, Diogo Turiani Hourneaux de Moura, Rubens Antonio Aissar Sallum, Ary Nasi, Sergio A Sánchez-Luna, Paulo Sakai, Eduardo Guimarães Hourneaux de Moura
Eduardo Turiani Hourneaux de Moura, Igor Braga Ribeiro, Paulo Sakai, Eduardo Guimarães Hourneaux de Moura, Departamento de Gastroenterologia, Faculdade de Medicina, Universidade de Sao Paulo, Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas HCFMUSP, Sao Paulo 05403-010, Brazil
José Jukemura, Rubens Antonio Aissar Sallum, Ary Nasi, Division of Esophageal Surgery, Hospital das Clínicas, University of São Paulo School of Medicine, Sao Paulo 05403-010, Brazil
Galileu Ferreira Ayala Farias, Aureo Augusto de Almeida Delgado, Lara Meireles Azeredo Coutinho, Diogo Turiani Hourneaux de Moura, Departamento de Gastroenterologia, Faculdade de Medicina, Universidade de Sao Paulo, Hospital das Clínicas, University of São Paulo School of Medicine, Sao Paulo 05403-010, Brazil
Sergio A Sánchez-Luna, Department of Internal Medicine, The University of Alabama at Birmingham Heersink School of Medicine, Basil I. Hirschowitz Endoscopic Center of Excellence, Division of Gastroenterology and Hepatology, Birmingham, AL 35233, United States
Author contributions: de Moura ETH contributed to the conception and design of the study; de Moura ETH, Ribeiro IB, de Moura DTH, Aissar Sallum RA, Nasi A, Sánchez-Luna SA, Sakai P, and de Moura EGH analyzed and interpreted the data, drafted the article, revised the article for important intellectual content, and approved the final version; Jukemura J, de Almeida Delgado AA, and Coutinho LMA analyzed and interpreted the data, revised the article for important intellectual content, and approved the final version; Farias GFA analyzed and interpreted the data, and approved the final version.
Institutional review board statement: The study was approved by the Research Ethics Committee of the University of São Paulo School of Medicine, No. CAAE: 23460613000000068.
Clinical trial registration statement: The trial was registered at ClinicalTrials.gov, No. NCT02138643.
Informed consent statement: All subjects agreed to participate in this study after informed consent and ethical permission were obtained.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: No additional data are available.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See:
https://creativecommons.org/Licenses/by-nc/4.0/ Corresponding author: Igor Braga Ribeiro, MD, PhD, Associate Research Scientist, Attending Doctor, Doctor, Research Scientist, Departamento de Gastroenterologia, Faculdade de Medicina, Universidade de Sao Paulo, Serviço de Endoscopia Gastrointestinal do Hospital das Clínicas HCFMUSP, Av. Dr Enéas de Carvalho Aguiar, 225, 6o Andar, Bloco 3, Cerqueira Cesar, Sao Paulo 05403-010, Brazil. igorbraga1@gmail.com
Received: May 4, 2022
Peer-review started: May 4, 2022
First decision: June 2, 2022
Revised: July 7, 2022
Accepted: August 6, 2022
Article in press: August 6, 2022
Published online: September 7, 2022
Processing time: 118 Days and 22.9 Hours
BACKGROUND
Achalasia is a rare benign esophageal motor disorder characterized by incomplete relaxation of the lower esophageal sphincter (LES). The treatment of achalasia is not curative, but rather is aimed at reducing LES pressure. In patients who have failed noninvasive therapy, surgery should be considered. Myotomy with partial fundoplication has been considered the first-line treatment for non-advanced achalasia. Recently, peroral endoscopic myotomy (POEM), a technique that employs the principles of submucosal endoscopy to perform the equivalent of a surgical myotomy, has emerged as a promising minimally invasive technique for the management of this condition.
AIM
To compare POEM and laparoscopic myotomy and partial fundoplication (LM-PF) regarding their efficacy and outcomes for the treatment of achalasia.
METHODS
Forty treatment-naive adult patients who had been diagnosed with achalasia based on clinical and manometric criteria (dysphagia score ≥ II and Eckardt score > 3) were randomized to undergo either LM-PF or POEM. The outcome measures were anesthesia time, procedure time, symptom improvement, reflux esophagitis (as determined with the Gastroesophageal Reflux Disease Questionnaire), barium column height at 1 and 5 min (on a barium esophagogram), pressure at the LES, the occurrence of adverse events (AEs), length of stay (LOS), and quality of life (QoL).
RESULTS
There were no statistically significant differences between the LM-PF and POEM groups regarding symptom improvement at 1, 6, and 12 mo of follow-up (P = 0.192, P = 0.242, and P = 0.242, respectively). However, the rates of reflux esophagitis at 1, 6, and 12 mo of follow-up were significantly higher in the POEM group (P = 0.014, P < 0.001, and P = 0.002, respectively). There were also no statistical differences regarding the manometry values, the occurrence of AEs, or LOS. Anesthesia time and procedure time were significantly shorter in the POEM group than in the LM-PF group (185.00 ± 56.89 and 95.70 ± 30.47 min vs 296.75 ± 56.13 and 218.75 ± 50.88 min, respectively; P = 0.001 for both). In the POEM group, there were improvements in all domains of the QoL questionnaire, whereas there were improvements in only three domains in the LM-PF group.
CONCLUSION
POEM and LM-PF appear to be equally effective in controlling the symptoms of achalasia, shortening LOS, and minimizing AEs. Nevertheless, POEM has the advantage of improving all domains of QoL, and shortening anesthesia and procedure times but with a significantly higher rate of gastroesophageal reflux.
Core Tip: This randomized controlled trial compared the efficacy and outcomes of laparoscopic myotomy and partial fundoplication (LM-PF) with those of peroral endoscopic myotomy (POEM) for the treatment of patients with achalasia of any etiology. There were no statistically significant differences between the LM-PF and POEM groups regarding symptoms. However, the rates of reflux esophagitis were significantly higher in the POEM group. POEM and LM-PF appear to be equally effective in controlling the symptoms of achalasia, shortening length of hospital stay, and minimizing adverse events. However, POEM has the advantage of shortening anesthesia and procedure times.
