Endoscopic Versus Robotic Myotomy for Treatment of Achalasia (ERMA)

March 3, 2024 updated by: Elisenda Garsot Savall, Germans Trias i Pujol Hospital

Endoscopic Versus Robotic Myotomy for Treatment of Achalasia (ERMA Trial)

Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of the esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms of this pathology. Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world. In recent years, a large amount of data examining the effectiveness of POEM have appeared, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90%. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. According to these data, it seems that the two procedures offer the same clinical results in the medium term. On the other hand, in recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy with a lower complication rate. Based on the evidence, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.

The purpose of the study is to evaluate the clinical and quality of life results of the RHM and compare them with the results of POEM in treatment of achalasia.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Achalasia is a primary esophageal motor disorder of unknown etiology characterized by degeneration of the myenteric plexus, resulting in impaired relaxation of esophagogastric junction (EGJ), along with loss of peristalsis in the esophageal body. The standard criteria for diagnosing achalasia is high-resolution esophageal manometry, which shows incomplete relaxation of the EGJ along with absence of esophageal body peristalsis. These anomalies usually cause dysphagia and regurgitation as the main symptoms. Three subtypes of achalasia have been defined based on the findings of high-resolution manometry in the esophageal body: type I or classic achalasia with low intraesophageal pressure, type II with panesophageal pressurization, and type III with high-amplitude spastic contractions.

Different treatment options have been described for this pathology, with pneumatic dilation (PD) and myotomy being considered first-line, whether surgical (laparoscopic Heller myotomy, LHM) or endoscopic (peroral endoscopic myotomy, POEM). PD is the most frequently performed treatment worldwide with a reported long-term effectiveness between 50-93%, although it is generally a procedure that requires multiple sessions. On the other hand, LHM combined with an antireflux procedure is a treatment that, despite being more invasive, in most cases requires only one treatment session and offers success rates of 71% to 92%. POEM is a recently emerging procedure but with a success rate in prospective cohorts that sometimes exceeds 90%.

Multiple studies have shown that treatment outcomes depend on the subtype of achalasia. Based on available data, pneumatic dilation, laparoscopic Heller myotomy and POEM are believed to be effective for achalasia type I and II, while POEM has emerged as the preferred treatment for achalasia type III, which is believed to be related to the ability to perform a proximal extended myotomy. The arrival of POEM as a less invasive alternative for the treatment of achalasia has revolutionized expectations to the point that it has become a routine procedure in many centers around the world that use it for the treatment of any type of achalasia. In recent years, there is a large amount of data examining the effectiveness of POEM, including several meta-analyses. The success rate of POEM in prospective cohorts has been greater than 90% and has been maintained across all achalasia subtypes. Two randomized studies have been published comparing POEM with LHM, providing a framework to evaluate the comparative efficacy and safety of these two interventions and to determine which should be first-line for the treatment of these patients. With these data, it seems that the two procedures offer the same clinical results in the medium term.

However, the main issue that POEM faces is the presence of post-procedure reflux. The incidence of reflux disease seems to be significantly higher after POEM compared to LHM with fundoplication but the way to evaluate the presence of reflux in these patients is variable between studies and it seems that this incidence could decrease one year after the procedure.

In recent years, there has been a growing expansion of the application of robot-assisted technology. Robotic Heller myotomy (RHM) has been proposed as an alternative minimally invasive approach to traditional laparoscopy. However, there are doubts regarding the increased cost, longer surgical times, and loss of tactile feedback associated with the robotic approach. A recent systematic review proposes it as an alternative with comparable results to conventional laparoscopy in terms of clinical results and associated morbidity and mortality. Furthermore, it seems that the robotic approach offers a decrease in the rate of mucosal perforation during the procedure that could be related to the greater precision that this technique offers in the dissection of the muscular layer, which ranges between 0-1% and is comparable to that offered by the POEM but lower than the LHM.

Therefore, POEM and RHM could have comparable results in short term, but there is no clear certainty about the results in medium-long term. Likewise, there is a lack of studies that confirm postoperative reflux results in both procedures.

The purpose of the study is evaluate the clinical and quality of life results of RHM and compare them with the results of POEM in the treatment of achalasia.

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08016
        • Elisenda Garsot Savall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients with symptomatic achalasia with an Eckardt score of > 3 and pre-op barium swallow, manometry and esophagogastroduodenoscopy consistent with the diagnosis
  2. Persons of age > 18 years with medical indication for surgical myotomy or EBD
  3. Signed written Informed Consent

Exclusion Criteria:

  1. Patients with previous surgery of the stomach or esophagus
  2. Patients with known coagulopathy
  3. Previous myotomy
  4. Patients with liver cirrhosis and/or esophageal varices
  5. Malignant esophageal lesion
  6. Hiatal hernia
  7. Extensive dilatation of the esophagus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Robotic Heller Myotomy.
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the Robotic Heller Myotomy group
Procedure: Robotic Heller Myotomy
Use five trocar technique with patient in the French position. Establish 12-15 mm Hg pneumoperitoneum. Divide phrenoesophageal ligament starting on the right and mobilize distal esophagus on the lateral and anterior side. Identify and spare anterior vagal nerve. Perform myotomy by dividing both muscle-layers extending at least 7 cm above gastroesophageal junction and 2 cm inferiorly over stomach. Measure myotomy length. Perform anterior fundoplication without mobilizeng fundus of the stomach by dividing short gastric vessels if not necessary. Suture fundus to both cut edges of myotomy, using non-resorbable material.
Active Comparator: Peroral Endoscopic Myotomy.
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the Peroral Endoscopic Myotomy group
Procedure: Peroral Endoscopic Myotomy
After lavage, measure gastro-esophageal junction (GEJ) in cm from mouth piece. Determine entry point 12-14cm above GEJ at the lesser curvature site, inject 10ml coloured saline, create entry point. Advance endoscope into the submucosa, dissect the submucosal tunnel up to 2-3cm into the cardia. Dissect the submucosa close to the muscularis and check endoluminally for the direction of the lesser curvature, sufficient extension onto the cardia and mucosal integrity. After tunnel completion flush with gentamycin and saline. Start myotomy from proximally to distally starting 4-5cm below the mucosal entry site; the inner circular muscle layer should be fully dissected especially at the cardia for good symptomatic results. It is vital that the mucosa of the tubular esophagus remains intact. Extend myotomy at least 2cm onto the cardia. After completion check for mucosal integrity and opening of the distal esophageal sphincter. Close the entry point with clips from distal to proximal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eckhard symptom scores
Time Frame: 6 months and 2 years after treatment
Achalasia symptom questionnaire to evaluate individual therapy success, range from 0 (no Achalasia symptoms) to 12 (full symptom range), treatment success is defined as an Eckardt Score ≤ 3
6 months and 2 years after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GERD-Q score
Time Frame: 6 months and 2 years after treatment
Gastroesophageal reflux questionaire to evaluate individual presence of postreatment reflux, range from 0 (no reflux symptoms) to 18 (full symptom range)
6 months and 2 years after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Germans Trias i Pujol Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 25, 2024

First Submitted That Met QC Criteria

February 26, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Estimated)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 3, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERMA trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Achalasia Cardia

Clinical Trials on Robotic Heller Myotomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe