Randomized Clinical Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastroenterol. Sep 7, 2022; 28(33): 4875-4889
Published online Sep 7, 2022. doi: 10.3748/wjg.v28.i33.4875
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
ARTICLE HIGHLIGHTS
Research 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 aimed at reducing the LES pressure. Surgical myotomy with partial fundoplication is traditional the gold standard method for the management of these patients. Peroral endoscopic myotomy (POEM) use its increasing due to it satisfactory results.

Research motivation

Since there is still no definition of the best treatment for achalasia, the objective of this study was to compare the techniques used.

Research objectives

This study aimed to compare POEM and laparoscopic myotomy and partial fundoplication (LM-PF) regarding their efficacy and outcomes for the treatment of achalasia.

Research methods

This was a single-center randomized controlled clinical trial.

Research results

There were no significant differences between the LM-PF and POEM groups regarding symptom improvement at 1, 6, and 12 mo of follow-up. Rates of reflux esophagitis were significantly higher in the POEM group. There were also no statistical differences regarding manometry values or the occurrence of adverse events or length of stay. Anesthesia time and procedure time were significantly shorter in the POEM group than in the LM-PF group. In the POEM group, there was an improvement in all domains of quality of life.

Research conclusions

POEM and LM-PF are equally effective in controlling symptoms of achalasia. POEM has the advantage of reducing anesthesia and procedure times, but with a significantly higher rate of gastroesophageal reflux.

Research perspectives

Future research should focus on long-term follow-up and outcomes of different techniques. It is possible that the improvement in the POEM technique may contribute to new perspectives on reflux symptoms.