Endoscopic Versus Robotic Myotomy for Treatment of Achalasia

NCT06290882 | Active Not Recruiting DMC

• 1 other identifier: ERMA trial
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Achalasia Cardia

Keywords

Achalasia; Robotic Heller Myotomy; Peroral Endoscopic Myotomy

Outcome Measures

Primary Outcomes (1)

• Eckhard symptom scores

  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 Outcomes (1)

• GERD-Q score

  6 months and 2 years after treatment

Study Arms (2)

Robotic Heller Myotomy.

ACTIVE COMPARATOR

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

Peroral Endoscopic Myotomy.

ACTIVE COMPARATOR

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

Interventions

Robotic Heller Myotomy PROCEDURE

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.

Robotic Heller Myotomy.

Peroral Endoscopic Myotomy PROCEDURE

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.

Peroral Endoscopic Myotomy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with previous surgery of the stomach or esophagus
• Patients with known coagulopathy
• Previous myotomy
• Patients with liver cirrhosis and/or esophageal varices
• Malignant esophageal lesion
• Hiatal hernia
• Extensive dilatation of the esophagus

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead

Study Sites (1)

Elisenda Garsot Savall

Badalona, Barcelona, 08016, Spain

Location

Related Publications (20)

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MeSH Terms

Conditions

Esophageal Achalasia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Upper GI section

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: March 4, 2024
• Study Start: January 1, 2024
• Primary Completion: January 31, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)