Endoscopic versus robotic myotomy for treatment of achalasia (ERMA trial): protocol for a randomized clinical multicentre trial

Various treatment options have been described for achalasia, with myotomy being considered the first-line approach, whether surgical (laparoscopic Heller myotomy (LHM)) or endoscopic (peroral endoscopic myotomy (POEM))¹. The advent of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the extent that it has become a routine procedure in many centres worldwide, with a reported success rate of up to 90%². Randomized studies comparing POEM with conventional surgical myotomy consistently demonstrate that POEM achieves similar results to LHM in terms of effectiveness and symptom control, albeit with a significantly higher incidence of gastroesophageal reflux³.

In recent years, there has been an increasing adoption of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as a minimally invasive alternative to traditional laparoscopy. A recent systematic review suggests that it offers comparable outcomes to conventional laparoscopy in terms of clinical results and morbidity and mortality rates. Furthermore, the robotic approach appears to reduce the rate of mucosal perforations during the procedure, likely due to the enhanced precision it provides in the dissection of the muscular layer⁴.

When comparing RHM with POEM, it seems that both offer results that are similar to, if not better than, conventional LHM⁵. However, to date, the choice between POEM or RHM is often dictated by the availability of specific technologies and the expertise of medical professionals. Not all centres are equipped with robotic surgery capabilities, and not all hospitals have endoscopists trained in advanced endoscopy techniques. This discrepancy frequently determines the type of myotomy performed on patients. In fact, there are no clear criteria to guide the selection of the most appropriate procedure for each patient.

The Spanish multicentre randomized trial of Endoscopic versus Robotic myotomy for Achalasia (ERMA trial) is an open-label multicentre randomized trial designed to analyse the clinical outcomes and quality of life resulting from RHM and to compare these with the results of POEM.

For this purpose, four tertiary centres with extensive experience in robotic surgery and advanced endoscopic procedures have been selected. Patients diagnosed with type 1 or 2 achalasia will be eligible to participate in the clinical trial. The primary endpoint is Eckardt score at 2 years. Secondary endpoints include Eckardt symptom scores at 3 and 6 months, and at 1, 2 and 3 years, manometry data, reflux symptoms (Gastro-Esophageal Reflux Disease Score (GERD-Q)), pH metry data, quality of life (Gastro-Intestinal Quality of Life Questionnaire (GIQoL) and Gastro-Esophageal Reflux Disease-Health Related Quality of Life Questionnaire (GERD-HRQL)), adverse events and 90-day mortality rate. Table 1 provides a comprehensive description of the parameters to be collected over the 3 years of follow-up.

Assuming success rates of 90% for both procedures, we estimated that each treatment group would require 72 evaluable patients for the trial to have 80% power to detect non-inferiority with respect to the primary endpoint.

The study will include both univariable and multivariable statistical analyses. Supervised and unsupervised machine learning algorithms will also be applied in the final stage of the study once all data has been collected. The complete protocol is detailed in the Supplementary material.

There is a notable lack of studies directly comparing POEM and RHM, which would provide essential tools for discerning the most suitable procedure for individual patients. To our knowledge, this is the first randomized multicentre study aimed at comparing the endoscopic with the robotic approach in the treatment of achalasia.

This trial received approval from the Hospital Universitari Germans Trias i Pujol Clinical Research Ethics Committee on 1 March 2024 (REF.CEI: PI-24-023) and was registered at clinicaltrials.gov of the US National Library of Medicine (registration number: NCT06290882) on 3 March 2024.

Funding

The authors have no funding to declare.

Disclosure

The authors declare no conflict of interest.

Supplementary material

Supplementary material is available at BJS Open online.

Data availability

The principal investigator at each centre will have full access only to their patients’ data, while E.G., as the principal investigator of the trial, will have full access to all study data. Each researcher will take responsibility for the integrity of the data and the accuracy of the data analysis. The data are not publicly available.

Author contributions

Elisenda Garsot (Conceptualization, Investigation, Methodology, Project administration, Resources, Supervision, Validation, Visualization, Writing—original draft, Writing—review & editing), Georgina Company (Data curation, Formal analysis, Methodology, Validation), Hugo Uchima (Conceptualization, Data curation, Investigation, Methodology, Supervision), Ingrid Marín (Conceptualization, Data curation, Investigation, Methodology, Validation), Marta Viciano (Investigation, Methodology), Arantxa Clavell (Investigation, Methodology), Sonia Fernández Ananin (Investigation, Methodology), Mònica Miró (Investigation, Methodology), Carlos Guarner (Investigation, Methodology), Joan Gornals (Investigation, Methodology), Carla Bettonica (Investigation, Methodology), Dulce Momblán (Investigation, Methodology), M Glòria Fernández Esparrach (Investigation, Methodology), Isis Araujo (Investigation, Methodology) and Lexa Nescolarde (Data curation, Formal analysis, Methodology, Writing—original draft)

References