AchalasiaPOEMrctNCT01601678
Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia
A study testing Peroral Endoscopic Myotomy (POEM) and Laparoscopic Heller Myotomy (LHM) in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in 6 countries.
Trial summary
Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus leading to dysphagia, regurgitation, and chest pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Achalasia
- What is being tested?
- Peroral Endoscopic Myotomy (POEM) and Laparoscopic Heller Myotomy (LHM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 8 sitesin 6 countries
- Study dates
- Dec 2012to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 surgical achalasia treatment
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
- Eosinophilic esophagitis
Show all 14Show fewer
- Barrett's esophagus
- Pregnancy
- Stricture of the esophagus
- Malignant or premalignant esophageal lesion
- Severe Candida esophagitis
- Hiatal hernia > 1cm
- Extensive tortuous dilatation (>7cm luminal diameter, S shape) of the esophagus
- Advanced malignant tumor with prognosis < 2 years
Trial locations and contacts
8 sites in 6 countries.
8 sites in 6 countries
Germany3 sites
Klinikum Augsburg,Klinik für Innere Medizin III
Augsburg, 86156
Universitätsklinikum Eppendorf
Hamburg, 20246
University Hospital Würzburg
Würzburg, 97080
Sweden1 site
Ersta Hospital and Karolinska University Hospital
Stockholm, S141 86
About this study
Official title: Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial
Achalasia is a rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus leading to dysphagia, regurgitation, and chest pain. therapies for achalasia consist of endoscopic balloon dilatation (EBD) and botulinum toxin injection (EBTI), or surgical Treatment via i Heller Myotomy; surgery is nowadays mostly performed via the laparoscopic approach. Surgical therapy demonstrated superior treatment efficacy compared to EBD and EBTI. Recently, an endoscopic means to perform myotomy via a submucosal tunnel has been developed, namely PerOral Endoscopic Myotomy (POEM). Uncontrolled studies have indicated a symptomatic success rate of >90% for POEM in short term follow-ups.The aim of this study is to compare short and long-term feasibility, safety and efficacy of endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.
Read the detailed description
Achalasia is considered a primary esophageal motility disorder which is defined as an insufficient relaxation of the lower esophageal sphincter. Incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus are characteristics of achalasia. Incidence peaks between ages 20 to 40. The most commonly reported symptoms are dysphagia (both for solids and liquids), regurgitation, and chest pain. The diagnosis is established with esophageal manometry and barium swallow radiographic studies and also with endoscopy being performed to exclude neoplastic or inflammatory diseases. Endoscopic therapies consist of either balloon dilatation (EBD) or Botulinum toxin injection (EBTI). The surgical treatment for achalasia is Heller Myotomy, nowadays almost exclusively performed laparoscopically.Superior to EBD and EBTI, surgical myotomy has shown sustained therapeutic efficacy in approximately 90% of patients which may be especially relevant for young patients with achalasia.
Recently an endoscopic technique to create myotomy via a submucosal tunnel has been developed, named PerOral Endoscopic Myotomy (POEM). The technique was first reported by Pasricha et al. in a porcine study, and Inoue et al. later reported the first clinical results in achalasia patients which showed significantly reduced dysphagia symptom scores and decreased resting lower esophageal sphincter (LES) pressures in 17 patients with a mean follow-up of 5 months . No serious complications related to POEM were encountered in this initial single-center trial. Several smaller pilot studies from Asia, Europe and USA have replicated the promising results regarding feasibility, safety and short-term efficacy,leading us to hope for a similar success rate along with reduced patient discomfort At present, POEM has the potential to be the first scarless flexible endosurgical intervention to become an established clinical treatment.The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. For POEM to be integrated into clinical routine, comparative data regarding safety and efficacy are necessary.Our study group intends to compare safety and long-term efficacy of POEM to laparoscopic Heller myotomy, the current gold-Standard, in a non-inferiority design.
Patients with symptomatic achalasia and medical indication for interventional therapy will be randomized to either POEM therapy or standard laparoscopic Heller myotomy (with anti-reflux procedure)(LHM). They will be followed up closely in a defined time pattern evolving individual life quality and achalasia scores as well as clinical scores and diagnostics over a period of 5 years.
Due to considerations concerning the comparability to other achalsia Trials (Boeckxstaens,NEJM 2011), in November 2012 primary outcome has been changed to Eckardt Score instead of lower sphicter pressure. Amendment was done before patient inclusion started. Sample size was not affected by amendment.
- Conditions
- Achalasia
- Being tested
- Peroral Endoscopic Myotomy (POEM), Laparoscopic Heller Myotomy (LHM)
- Keywords
- Achalasia, Heller Myotomy, Dysphagia, Peroral Endoscopic Myotomy, LHM, POEM
- Medical subject headings
- Esophageal Achalasia, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral Endoscopic Myotomy (POEM)Procedure 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.
Laparoscopic Heller Myotomy (LHM)Procedure or surgery
Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. 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 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material.
| Study group | Role | What they receive |
|---|---|---|
| Peroral Endoscopic Myotomy POEM | Active comparator | Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group Receives: Procedure: Peroral Endoscopic Myotomy (POEM) |
| Laparoscopic Heller Myotomy LHM | Active comparator | Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group. Receives: Procedure: Laparoscopic Heller Myotomy (LHM) |
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: 2 years after treatment
Secondary outcomes (17)
Eckhard symptom scores
Achalasia symptom questionnaire to evaluate individual therapy success, range from 0 (no Achalasia symptoms) to 12 (full symptom range)
Measured: before,and 3 and 6 months, 1,3 and 5 years past procedure
Treatment success rates
success rates result from Eckardt Scores
Measured: 3 and 6 months, and 1, 3, and 5 years post procedure
Manometry data
Achalasia subtypes (before treatment) and assessment of lower esophagus sphincter function
Measured: before, and 3 months, and 2 and 5 years post procedure
Reflux score (clinical DeMeester score)
clinical DeMeester Reflux questionnaire to evaluate therapeutic side effects, range from 0 (no Reflux symptoms) to 6 (full symptom range).
Measured: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure
Reflux symptoms
List of side effects due to reflux past POEM as short term and long term outcomes
Measured: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure
pH metry
pH metry data after therapy
Measured: 3 months and 2 and 5 years after therapy
Adverse Events
complication rate (Adverse Events (AE) and Serious Adverse Events (SAE))
Measured: Baseline to five years past procedure
Quality of Life index
Life quality assessment (gastrointestinal LQ index by Eypasch, Wood-Dauphinee and Troidl) for individual success Evaluation (GIQLI), Best outcome score is 144.
Measured: before, and 3 months, and 2 and 5 years post procedure
EGD findings
EGD findings to evaluate reflux effects after therapy
Measured: 3 months and (optional) 2 and 5 years after therapy
CRP lab values
CRP values measured in mg/l (milligrams per litre) pre and post procedure
Measured: day before procedure to day after procedure
Hb lab values
Hemoglobin values measured in g/dl (grams per decilitre) pre and post procedure
Measured: day before procedure to day after procedure
Leucocyte lab values
Leucocyte values measured in billions per litre pre and post procedure, number of days of hospitalisation, myotomy length, duration of procedure
Measured: day before procedure to day after procedure
number of days of hospitalisation
inhouse stay after procedure
Measured: through inhouse stay after procedure, an average of 2-7 days
myotomy length
myotomy length in cm
Measured: day of procedure
duration of procedure
duration of procedure in minutes
Measured: day of procedure
Therapy failures
number of therapy failures
Measured: from procedure to 5 years after procedure
Retreatments
number and kinds of retreatments
Measured: from procedure to 5 years after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2012 (estimated)
- Study startDec 2012
- Primary completion30 May 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for AchalasiaStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska University Hospital, Institute for Clinical and Experimental Medicine, Universitaire Ziekenhuizen KU Leuven, Istituto Clinico Humanitas, Wuerzburg University Hospital, University Hospital Augsburg
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Roesch, Prof., Study director, Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, GermanyPaul Fockens, Prof., Principal investigator, Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; NetherlandsBengt Håkanson, Prof., Principal investigator, Department of Surgery, Karolinska University Hospital, Stockholm, SwedenGuy Boeckxstaens, Prof., Principal investigator, Universitaire Ziekenhuizen KU LeuvenC.T. Germer, Prof., Principal investigator, Wuerzburg University HospitalRiccardo Repici, Prof., Principal investigator, Istituto Clinico Humanitas, Rozzano, ItalyUberto Fumagalli, Prof., Principal investigator, Istituto Clinico Humanitas, Rozzano, ItalyJulius Spicak, Prof., Principal investigator, University Hospital Prague, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01601678
- Sponsor's protocol ID
- POEM vs. LHM
- Other IDs
- PV 4133
- Acronym
- POEMrct
- Status last verified
- Jun 2023
- First submitted
- 15 May 2012
- Last updated
- 28 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstatter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg. 2009 Jan;249(1):45-57. doi: 10.1097/SLA.0b013e31818e43ab.
PubMed 19106675von Rahden BH, Germer CT. [Laparoscopic myotomy for achalasia is clearly superior to the endoscopic treatment]. Chirurg. 2010 Jan;81(1):69-70. doi: 10.1007/s00104-009-1840-7. No abstract available. German.
PubMed 19940967Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.
PubMed 19092347Ortiz A, de Haro LF, Parrilla P, Lage A, Perez D, Munitiz V, Ruiz D, Molina J. Very long-term objective evaluation of heller myotomy plus posterior partial fundoplication in patients with achalasia of the cardia. Ann Surg. 2008 Feb;247(2):258-64. doi: 10.1097/SLA.0b013e318159d7dd.
PubMed 18216530Perretta S, Dallemagne B, Allemann P, Marescaux J. Multimedia manuscript. Heller myotomy and intraluminal fundoplication: a NOTES technique. Surg Endosc. 2010 Nov;24(11):2903. doi: 10.1007/s00464-010-1073-3. Epub 2010 Apr 29.
PubMed 20428893Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
PubMed 17703382Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
PubMed 20354937von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
PubMed 22068665Swanstrom LL, Rieder E, Dunst CM. A stepwise approach and early clinical experience in peroral endoscopic myotomy for the treatment of achalasia and esophageal motility disorders. J Am Coll Surg. 2011 Dec;213(6):751-6. doi: 10.1016/j.jamcollsurg.2011.09.001. Epub 2011 Oct 13.
PubMed 21996484Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
PubMed 21561346ZHOU PH, CAI MY, YAO LQ, ZHONG YS, REN Z, XU MD, CHEN WF, QIN XY. [Peroral endoscopic myotomy for esophageal achalasia: report of 42 cases]. Zhonghua Wei Chang Wai Ke Za Zhi. 2011 Sep;14(9):705-8. Chinese.
PubMed 21948538Smith CD, Stival A, Howell DL, Swafford V. Endoscopic therapy for achalasia before Heller myotomy results in worse outcomes than heller myotomy alone. Ann Surg. 2006 May;243(5):579-84; discussion 584-6. doi: 10.1097/01.sla.0000217524.75529.2d.
PubMed 16632991Hugova K, Mares J, Hakanson B, Repici A, von Rahden BHA, Bredenoord AJ, Bisschops R, Messmann H, Ruppenthal T, Mann O, Izbicki J, Harustiak T, Fumagalli Romario U, Rosati R, Germer CT, Schijven M, Emmermann A, von Renteln D, Dautel S, Fockens P, Boeckxstaens G, Rosch T, Martinek J, Werner YB. Per-oral endoscopic myotomy versus laparoscopic Heller's myotomy plus Dor fundoplication in patients with idiopathic achalasia: 5-year follow-up of a multicentre, randomised, open-label, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 May;10(5):431-441. doi: 10.1016/S2468-1253(25)00012-3. Epub 2025 Mar 17.
PubMed 40112837Werner 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 31800987
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01601678
- Acronym / sponsor ID
- POEMrct / POEM vs. LHM
- Conditions
- Achalasia
- Keywords
- Achalasia, Heller Myotomy, Dysphagia, Peroral Endoscopic Myotomy, LHM, POEM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Karolinska University Hospital, Institute for Clinical and Experimental Medicine, Universitaire Ziekenhuizen KU Leuven, Istituto Clinico Humanitas, Wuerzburg University Hospital, University Hospital Augsburg
- Study start
- Dec 2012 (actual)
- Primary completion
- 30 May 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 18 May 2012 (estimated)
- 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 rare neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus leading to dysphagia, regurgitation, and chest pain. therapies for achalasia consist of endoscopic balloon dilatation (EBD) and botulinum toxin injection (EBTI), or surgical Treatment via i Heller Myotomy; surgery is nowadays mostly performed via the laparoscopic approach. Surgical therapy demonstrated superior treatment efficacy compared to EBD and EBTI. Recently, an endoscopic means to perform myotomy via a submucosal tunnel has been developed, namely PerOral Endoscopic Myotomy (POEM). Uncontrolled studies have indicated a symptomatic success rate of >90% for POEM in short term follow-ups.The aim of this study is to compare short and long-term feasibility, safety and efficacy of endoscopic (POEM) with laparoscopic myotomy (Heller myotomy) in the treatment of achalasia.
Detailed description
Achalasia is considered a primary esophageal motility disorder which is defined as an insufficient relaxation of the lower esophageal sphincter. Incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus are characteristics of achalasia. Incidence peaks between ages 20 to 40. The most commonly reported symptoms are dysphagia (both for solids and liquids), regurgitation, and chest pain. The diagnosis is established with esophageal manometry and barium swallow radiographic studies and also with endoscopy being performed to exclude neoplastic or inflammatory diseases. Endoscopic therapies consist of either balloon dilatation (EBD) or Botulinum toxin injection (EBTI). The surgical treatment for achalasia is Heller Myotomy, nowadays almost exclusively performed laparoscopically.Superior to EBD and EBTI, surgical myotomy has shown sustained therapeutic efficacy in approximately 90% of patients which may be especially relevant for young patients with achalasia.
Recently an endoscopic technique to create myotomy via a submucosal tunnel has been developed, named PerOral Endoscopic Myotomy (POEM). The technique was first reported by Pasricha et al. in a porcine study, and Inoue et al. later reported the first clinical results in achalasia patients which showed significantly reduced dysphagia symptom scores and decreased resting lower esophageal sphincter (LES) pressures in 17 patients with a mean follow-up of 5 months . No serious complications related to POEM were encountered in this initial single-center trial. Several smaller pilot studies from Asia, Europe and USA have replicated the promising results regarding feasibility, safety and short-term efficacy,leading us to hope for a similar success rate along with reduced patient discomfort At present, POEM has the potential to be the first scarless flexible endosurgical intervention to become an established clinical treatment.The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. For POEM to be integrated into clinical routine, comparative data regarding safety and efficacy are necessary.Our study group intends to compare safety and long-term efficacy of POEM to laparoscopic Heller myotomy, the current gold-Standard, in a non-inferiority design.
Patients with symptomatic achalasia and medical indication for interventional therapy will be randomized to either POEM therapy or standard laparoscopic Heller myotomy (with anti-reflux procedure)(LHM). They will be followed up closely in a defined time pattern evolving individual life quality and achalasia scores as well as clinical scores and diagnostics over a period of 5 years.
Due to considerations concerning the comparability to other achalsia Trials (Boeckxstaens,NEJM 2011), in November 2012 primary outcome has been changed to Eckardt Score instead of lower sphicter pressure. Amendment was done before patient inclusion started. Sample size was not affected by amendment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peroral Endoscopic Myotomy POEM | Active comparator | Procedure: Peroral Endoscopic Myotomy (POEM)Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group |
| Laparoscopic Heller Myotomy LHM | Active comparator | Procedure: Laparoscopic Heller Myotomy (LHM)Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy 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 (14 listed)
- Patients with previous surgery of the stomach or esophagus
- Patients with known coagulopathy
- Previous surgical achalasia treatment
- Patients with liver cirrhosis and/or esophageal varices
- Active esophagitis
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 |
|---|---|---|
| Peroral Endoscopic Myotomy (POEM)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. | Procedure or surgery | Peroral Endoscopic Myotomy POEM |
| Laparoscopic Heller Myotomy (LHM)Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. 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 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material. | Procedure or surgery | Laparoscopic Heller Myotomy LHM |
Primary outcome
Eckhard symptom scores
Time frame: 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
17 secondary outcomes
Eckhard symptom scores
Time frame: before,and 3 and 6 months, 1,3 and 5 years past procedure
Treatment success rates
Time frame: 3 and 6 months, and 1, 3, and 5 years post procedure
Manometry data
Time frame: before, and 3 months, and 2 and 5 years post procedure
Reflux score (clinical DeMeester score)
Time frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure
Reflux symptoms
Time frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure
pH metry
Time frame: 3 months and 2 and 5 years after therapy
Adverse Events
Time frame: Baseline to five years past procedure
Quality of Life index
Time frame: before, and 3 months, and 2 and 5 years post procedure
EGD findings
Time frame: 3 months and (optional) 2 and 5 years after therapy
CRP lab values
Time frame: day before procedure to day after procedure
Hb lab values
Time frame: day before procedure to day after procedure
Leucocyte lab values
Time frame: day before procedure to day after procedure
number of days of hospitalisation
Time frame: through inhouse stay after procedure, an average of 2-7 days
myotomy length
Time frame: day of procedure
duration of procedure
Time frame: day of procedure
Therapy failures
Time frame: from procedure to 5 years after procedure
Retreatments
Time frame: from procedure to 5 years after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Background: PubMed 19106675Campos GM, Vittinghoff E, Rabl C, Takata M, Gadenstatter M, Lin F, Ciovica R. Endoscopic and surgical treatments for achalasia: a systematic review and meta-analysis. Ann Surg. 2009 Jan;249(1):45-57. doi: 10.1097/SLA.0b013e31818e43ab.
- Background: PubMed 19940967von Rahden BH, Germer CT. [Laparoscopic myotomy for achalasia is clearly superior to the endoscopic treatment]. Chirurg. 2010 Jan;81(1):69-70. doi: 10.1007/s00104-009-1840-7. No abstract available. German.
- Background: PubMed 19092347Rebecchi F, Giaccone C, Farinella E, Campaci R, Morino M. Randomized controlled trial of laparoscopic Heller myotomy plus Dor fundoplication versus Nissen fundoplication for achalasia: long-term results. Ann Surg. 2008 Dec;248(6):1023-30. doi: 10.1097/SLA.0b013e318190a776.
- Background: PubMed 18216530Ortiz A, de Haro LF, Parrilla P, Lage A, Perez D, Munitiz V, Ruiz D, Molina J. Very long-term objective evaluation of heller myotomy plus posterior partial fundoplication in patients with achalasia of the cardia. Ann Surg. 2008 Feb;247(2):258-64. doi: 10.1097/SLA.0b013e318159d7dd.
- Background: PubMed 20428893Perretta S, Dallemagne B, Allemann P, Marescaux J. Multimedia manuscript. Heller myotomy and intraluminal fundoplication: a NOTES technique. Surg Endosc. 2010 Nov;24(11):2903. doi: 10.1007/s00464-010-1073-3. Epub 2010 Apr 29.
- Background: PubMed 17703382Pasricha PJ, Hawari R, Ahmed I, Chen J, Cotton PB, Hawes RH, Kalloo AN, Kantsevoy SV, Gostout CJ. Submucosal endoscopic esophageal myotomy: a novel experimental approach for the treatment of achalasia. Endoscopy. 2007 Sep;39(9):761-4. doi: 10.1055/s-2007-966764.
- Background: PubMed 20354937Inoue H, Minami H, Kobayashi Y, Sato Y, Kaga M, Suzuki M, Satodate H, Odaka N, Itoh H, Kudo S. Peroral endoscopic myotomy (POEM) for esophageal achalasia. Endoscopy. 2010 Apr;42(4):265-71. doi: 10.1055/s-0029-1244080. Epub 2010 Mar 30.
- Background: PubMed 22068665von Renteln D, Inoue H, Minami H, Werner YB, Pace A, Kersten JF, Much CC, Schachschal G, Mann O, Keller J, Fuchs KH, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: a prospective single center study. Am J Gastroenterol. 2012 Mar;107(3):411-7. doi: 10.1038/ajg.2011.388. Epub 2011 Nov 8.
- Background: PubMed 21996484Swanstrom LL, Rieder E, Dunst CM. A stepwise approach and early clinical experience in peroral endoscopic myotomy for the treatment of achalasia and esophageal motility disorders. J Am Coll Surg. 2011 Dec;213(6):751-6. doi: 10.1016/j.jamcollsurg.2011.09.001. Epub 2011 Oct 13.
- Background: PubMed 21561346Boeckxstaens GE, Annese V, des Varannes SB, Chaussade S, Costantini M, Cuttitta A, Elizalde JI, Fumagalli U, Gaudric M, Rohof WO, Smout AJ, Tack J, Zwinderman AH, Zaninotto G, Busch OR; European Achalasia Trial Investigators. Pneumatic dilation versus laparoscopic Heller's myotomy for idiopathic achalasia. N Engl J Med. 2011 May 12;364(19):1807-16. doi: 10.1056/NEJMoa1010502.
- Background: PubMed 21948538ZHOU PH, CAI MY, YAO LQ, ZHONG YS, REN Z, XU MD, CHEN WF, QIN XY. [Peroral endoscopic myotomy for esophageal achalasia: report of 42 cases]. Zhonghua Wei Chang Wai Ke Za Zhi. 2011 Sep;14(9):705-8. Chinese.
- Background: PubMed 16632991Smith CD, Stival A, Howell DL, Swafford V. Endoscopic therapy for achalasia before Heller myotomy results in worse outcomes than heller myotomy alone. Ann Surg. 2006 May;243(5):579-84; discussion 584-6. doi: 10.1097/01.sla.0000217524.75529.2d.
- 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.
Thomas Roesch, Prof. study director
Interdisciplinary Endoscopy Department and Clinic, University Hospital Hamburg-Eppendorf, Germany
Paul Fockens, Prof. principal investigator
Department of Gastroenterology and Hepatology, Academic Medical Center, Amsterdam; Netherlands
Bengt Håkanson, Prof. principal investigator
Department of Surgery, Karolinska University Hospital, Stockholm, Sweden
8 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroral Endoscopic Myotomy (POEM) and Laparoscopic Heller Myotomy (LHM) in people with Achalasia, run by Universitätsklinikum Hamburg-Eppendorf at 8 sites in 6 countries.
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 14 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: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, Belgium, Czechia, Italy, Netherlands and 1 more country. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 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 NCT01601678, which also lists 14 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 28 Jun 2023.