Endoscopic Versus Robotic Myotomy for Treatment of Achalasia

Not Applicable

Active, not recruiting

• Conditions: Achalasia Cardia
• Interventions: Procedure: Robotic Heller Myotomy; Procedure: Peroral Endoscopic Myotomy

• Registration Number: NCT06290882
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

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 Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-02-26
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Study First Posted: 2024-03-04
• Last Update Posted: 2024-03-05
• Primary Completion: 2026-01-31
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic Heller Myotomy.	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
Peroral Endoscopic Myotomy.	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

Primary Outcome Measures

Name	Time	Method
Eckhard symptom scores	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

Secondary Outcome Measures

Name	Time	Method
GERD-Q score	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)

Trial Locations

Locations (1)

Elisenda Garsot Savall; 🇪🇸 Badalona, Barcelona, Spain