Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290882
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-25
Brief Title:
Endoscopic Versus Robotic Myotomy for Treatment of Achalasia
Sponsor:
Germans Trias i Pujol Hospital
Organization:
Germans Trias i Pujol Hospital
Study Overview
Official Title:
Endoscopic Versus Robotic Myotomy for Treatment of Achalasia ERMA Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERMA
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None