Achalasia CardiaERMANCT06290882
Endoscopic Versus Robotic Myotomy for Treatment of Achalasia
A study testing Robotic Heller Myotomy and Peroral Endoscopic Myotomy in people with Achalasia Cardia, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia Cardia
- What is being tested?
- Robotic Heller Myotomy and Peroral Endoscopic Myotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Achalasia Cardia
- Being tested
- Robotic Heller Myotomy, Peroral Endoscopic Myotomy
- Keywords
- Achalasia, Robotic Heller Myotomy, Peroral Endoscopic Myotomy
- Medical subject headings
- Esophageal Achalasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic Heller MyotomyProcedure or surgery
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.
Peroral Endoscopic MyotomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Peroral Endoscopic Myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months and 2 years after treatment
Secondary outcomes (1)
GERD-Q score
Gastroesophageal reflux questionaire to evaluate individual presence of postreatment reflux, range from 0 (no reflux symptoms) to 18 (full symptom range)
Measured: 6 months and 2 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Jan 2024
- Primary completion31 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Achalasia CardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisenda Garsot Savall, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290882
- Sponsor's protocol ID
- ERMA trial
- Acronym
- ERMA
- Status last verified
- Mar 2024
- First submitted
- 25 Jan 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khashab MA, Vela MF, Thosani N, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Jamil LH, Jue TL, Kannadath BS, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Yang J, Wani S. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020 Feb;91(2):213-227.e6. doi: 10.1016/j.gie.2019.04.231. Epub 2019 Dec 13.
PubMed 31839408Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.
PubMed 18722376Aiolfi A, Bona D, Riva CG, Micheletto G, Rausa E, Campanelli G, Olmo G, Bonitta G, Bonavina L. Systematic Review and Bayesian Network Meta-Analysis Comparing Laparoscopic Heller Myotomy, Pneumatic Dilatation, and Peroral Endoscopic Myotomy for Esophageal Achalasia. J Laparoendosc Adv Surg Tech A. 2020 Feb;30(2):147-155. doi: 10.1089/lap.2019.0432. Epub 2019 Jul 31.
PubMed 31364910Zhang H, Zeng X, Huang S, Shi L, Xia H, Jiang J, Ren W, Peng Y, Lu M, Tang X. Mid-Term and Long-Term Outcomes of Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2023 Apr;68(4):1386-1396. doi: 10.1007/s10620-022-07720-4. Epub 2022 Oct 19.
PubMed 36260203Rohof WO, Salvador R, Annese V, Bruley des Varannes S, Chaussade S, Costantini M, Elizalde JI, Gaudric M, Smout AJ, Tack J, Busch OR, Zaninotto G, Boeckxstaens GE. Outcomes of treatment for achalasia depend on manometric subtype. Gastroenterology. 2013 Apr;144(4):718-25; quiz e13-4. doi: 10.1053/j.gastro.2012.12.027. Epub 2012 Dec 28.
PubMed 23277105Pratap N, Kalapala R, Darisetty S, Joshi N, Ramchandani M, Banerjee R, Lakhtakia S, Gupta R, Tandan M, Rao GV, Reddy DN. Achalasia cardia subtyping by high-resolution manometry predicts the therapeutic outcome of pneumatic balloon dilatation. J Neurogastroenterol Motil. 2011 Jan;17(1):48-53. doi: 10.5056/jnm.2011.17.1.48. Epub 2011 Jan 26.
PubMed 21369491Salvador R, Costantini M, Zaninotto G, Morbin T, Rizzetto C, Zanatta L, Ceolin M, Finotti E, Nicoletti L, Da Dalt G, Cavallin F, Ancona E. The preoperative manometric pattern predicts the outcome of surgical treatment for esophageal achalasia. J Gastrointest Surg. 2010 Nov;14(11):1635-45. doi: 10.1007/s11605-010-1318-4. Epub 2010 Sep 10.
PubMed 20830530Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJPM, Pandolfino JE; International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the management of oesophageal motility disorders in the era of high-resolution manometry: a focus on achalasia syndromes. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):677-688. doi: 10.1038/nrgastro.2017.132. Epub 2017 Sep 27.
PubMed 28951579Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Epub 2015 Jul 14.
PubMed 26175119Akintoye E, Kumar N, Obaitan I, Alayo QA, Thompson CC. Peroral endoscopic myotomy: a meta-analysis. Endoscopy. 2016 Dec;48(12):1059-1068. doi: 10.1055/s-0042-114426. Epub 2016 Sep 12.
PubMed 27617421Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380.
PubMed 31800987Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859.
PubMed 31287522Facciorusso A, Singh S, Abbas Fehmi SM, Annese V, Lipham J, Yadlapati R. Comparative efficacy of first-line therapeutic interventions for achalasia: a systematic review and network meta-analysis. Surg Endosc. 2021 Aug;35(8):4305-4314. doi: 10.1007/s00464-020-07920-x. Epub 2020 Aug 27.
PubMed 32856150Ciomperlik H, Dhanani NH, Mohr C, Hannon C, Olavarria OA, Holihan JL, Liang MK. Systematic Review of Treatment of Patients with Achalasia: Heller Myotomy, Pneumatic Dilation, and Peroral Endoscopic Myotomy. J Am Coll Surg. 2023 Mar 1;236(3):523-532. doi: 10.1097/XCS.0000000000000484. Epub 2022 Nov 16.
PubMed 36382896Schlottmann F, Luckett DJ, Fine J, Shaheen NJ, Patti MG. Laparoscopic Heller Myotomy Versus Peroral Endoscopic Myotomy (POEM) for Achalasia: A Systematic Review and Meta-analysis. Ann Surg. 2018 Mar;267(3):451-460. doi: 10.1097/SLA.0000000000002311.
PubMed 28549006
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Robotic Myotomy for Treatment of Achalasia (ERMA Trial)
- ClinicalTrials.gov ID
- NCT06290882
- Acronym / sponsor ID
- ERMA / ERMA trial
- Conditions
- Achalasia Cardia
- Keywords
- Achalasia, Robotic Heller Myotomy, Peroral Endoscopic Myotomy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Robotic Heller Myotomy. | Active comparator | Procedure: Robotic Heller MyotomyPatients 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. | Active comparator | Procedure: Peroral Endoscopic MyotomyPatients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the Peroral Endoscopic Myotomy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic Heller MyotomyUse 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. | Procedure or surgery | Robotic Heller Myotomy. |
| Peroral Endoscopic MyotomyAfter 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. | Procedure or surgery | Peroral Endoscopic Myotomy. |
Primary outcome
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
1 secondary outcome
GERD-Q score
Time frame: 6 months and 2 years after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Background: PubMed 31839408Khashab MA, Vela MF, Thosani N, Agrawal D, Buxbaum JL, Abbas Fehmi SM, Fishman DS, Gurudu SR, Jamil LH, Jue TL, Kannadath BS, Law JK, Lee JK, Naveed M, Qumseya BJ, Sawhney MS, Yang J, Wani S. ASGE guideline on the management of achalasia. Gastrointest Endosc. 2020 Feb;91(2):213-227.e6. doi: 10.1016/j.gie.2019.04.231. Epub 2019 Dec 13.
- Background: PubMed 18722376Pandolfino JE, Kwiatek MA, Nealis T, Bulsiewicz W, Post J, Kahrilas PJ. Achalasia: a new clinically relevant classification by high-resolution manometry. Gastroenterology. 2008 Nov;135(5):1526-33. doi: 10.1053/j.gastro.2008.07.022. Epub 2008 Jul 22.
- Background: PubMed 31364910Aiolfi A, Bona D, Riva CG, Micheletto G, Rausa E, Campanelli G, Olmo G, Bonitta G, Bonavina L. Systematic Review and Bayesian Network Meta-Analysis Comparing Laparoscopic Heller Myotomy, Pneumatic Dilatation, and Peroral Endoscopic Myotomy for Esophageal Achalasia. J Laparoendosc Adv Surg Tech A. 2020 Feb;30(2):147-155. doi: 10.1089/lap.2019.0432. Epub 2019 Jul 31.
- Background: PubMed 36260203Zhang H, Zeng X, Huang S, Shi L, Xia H, Jiang J, Ren W, Peng Y, Lu M, Tang X. Mid-Term and Long-Term Outcomes of Peroral Endoscopic Myotomy for the Treatment of Achalasia: A Systematic Review and Meta-Analysis. Dig Dis Sci. 2023 Apr;68(4):1386-1396. doi: 10.1007/s10620-022-07720-4. Epub 2022 Oct 19.
- Background: PubMed 23277105Rohof WO, Salvador R, Annese V, Bruley des Varannes S, Chaussade S, Costantini M, Elizalde JI, Gaudric M, Smout AJ, Tack J, Busch OR, Zaninotto G, Boeckxstaens GE. Outcomes of treatment for achalasia depend on manometric subtype. Gastroenterology. 2013 Apr;144(4):718-25; quiz e13-4. doi: 10.1053/j.gastro.2012.12.027. Epub 2012 Dec 28.
- Background: PubMed 21369491Pratap N, Kalapala R, Darisetty S, Joshi N, Ramchandani M, Banerjee R, Lakhtakia S, Gupta R, Tandan M, Rao GV, Reddy DN. Achalasia cardia subtyping by high-resolution manometry predicts the therapeutic outcome of pneumatic balloon dilatation. J Neurogastroenterol Motil. 2011 Jan;17(1):48-53. doi: 10.5056/jnm.2011.17.1.48. Epub 2011 Jan 26.
- Background: PubMed 20830530Salvador R, Costantini M, Zaninotto G, Morbin T, Rizzetto C, Zanatta L, Ceolin M, Finotti E, Nicoletti L, Da Dalt G, Cavallin F, Ancona E. The preoperative manometric pattern predicts the outcome of surgical treatment for esophageal achalasia. J Gastrointest Surg. 2010 Nov;14(11):1635-45. doi: 10.1007/s11605-010-1318-4. Epub 2010 Sep 10.
- Background: PubMed 28951579Kahrilas PJ, Bredenoord AJ, Fox M, Gyawali CP, Roman S, Smout AJPM, Pandolfino JE; International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the management of oesophageal motility disorders in the era of high-resolution manometry: a focus on achalasia syndromes. Nat Rev Gastroenterol Hepatol. 2017 Nov;14(11):677-688. doi: 10.1038/nrgastro.2017.132. Epub 2017 Sep 27.
- Background: PubMed 26175119Patel K, Abbassi-Ghadi N, Markar S, Kumar S, Jethwa P, Zaninotto G. Peroral endoscopic myotomy for the treatment of esophageal achalasia: systematic review and pooled analysis. Dis Esophagus. 2016 Oct;29(7):807-819. doi: 10.1111/dote.12387. Epub 2015 Jul 14.
- Background: PubMed 27617421Akintoye E, Kumar N, Obaitan I, Alayo QA, Thompson CC. Peroral endoscopic myotomy: a meta-analysis. Endoscopy. 2016 Dec;48(12):1059-1068. doi: 10.1055/s-0042-114426. Epub 2016 Sep 12.
- Background: PubMed 31800987Werner YB, Hakanson B, Martinek J, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Vollberg MC, Noder T, Kersten JF, Mann O, Izbicki J, Pazdro A, Fumagalli U, Rosati R, Germer CT, Schijven MP, Emmermann A, von Renteln D, Fockens P, Boeckxstaens G, Rosch T. Endoscopic or Surgical Myotomy in Patients with Idiopathic Achalasia. N Engl J Med. 2019 Dec 5;381(23):2219-2229. doi: 10.1056/NEJMoa1905380.
- Background: PubMed 31287522Ponds FA, Fockens P, Lei A, Neuhaus H, Beyna T, Kandler J, Frieling T, Chiu PWY, Wu JCY, Wong VWY, Costamagna G, Familiari P, Kahrilas PJ, Pandolfino JE, Smout AJPM, Bredenoord AJ. Effect of Peroral Endoscopic Myotomy vs Pneumatic Dilation on Symptom Severity and Treatment Outcomes Among Treatment-Naive Patients With Achalasia: A Randomized Clinical Trial. JAMA. 2019 Jul 9;322(2):134-144. doi: 10.1001/jama.2019.8859.
- Individual participant dataSharing planned: No
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Achalasia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic Heller Myotomy and Peroral Endoscopic Myotomy in people with Achalasia Cardia, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eckhard symptom scores (time frame: 6 months and 2 years after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06290882, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.