Comparison of Short- Term Success Rates of POEM With LHMPOEM3NCT02018705
Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia
An observational study of Comparison of Short- Term Success Rates of POEM With LHM and Comparison of Long-term Success Rates of POEM With LHM, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 4 countries.
Trial summary
For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparison of Short- Term Success Rates of POEM With LHM, Comparison of Long-term Success Rates of POEM With LHM
- How many people
- 47 participants
- Where
- 5 sitesin 4 countries
- Study dates
- Aug 2013to Dec 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Achalasia patients who have been treated with either POEM or LHM
Who may be able to join
- Patients with symptomatic achalasia and pre-op barium swallow, manometry and oesophago-gastro-duodenoscopy which have been consistent with the diagnosis
- Age > 18 years with medical indication for interventional achalasia treatment
- Availability of Eckardt score at baseline and 12 months after initial treatment
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 12Show fewer
- Barrett's esophagus
- 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
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Germany2 sites
University Hospital Eppendorf
Hamburg, 20246
University Medical Center
Mainz, 55131
About this study
Official title: Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study
For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, long-term comparative data with LHM is required. Therefore,the intention for this study is to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.
Read the detailed description
Achalasia is a neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. The standard surgical treatment for achalasia is laparoscopic Heller Myotomy (LHM). A recent meta-analysis of 105 studies reporting on 7855 patients demonstrated that laparoscopic Heller myotomy is the most effective and long-lasting therapy for achalasia. Superior to Endoscopic balloon dilatation or Botulinumtoxin injection LHM has a one year therapeutic efficacy in approximately 90% of patients. Recently an endoscopic technique emulating the principles of LHM was developed. This technique of a purely endoscopic myotomy has been demonstrated by Pasricha et al. in animal experiments and Inoue et al. reported the first clinical study. Other pilot studies and a larger international multi-center trial have replicated promising results for POEM.
Uncontrolled studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, however, comparative data with LHM is required. Our study group intends to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.
- Conditions
- Comparison of Short- Term Success Rates of POEM With LHM, Comparison of Long-term Success Rates of POEM With LHM
- Keywords
- POEM, LHM, Achalasia treatment, LES sphincter myotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| POEM | group of Achalasia patients treated with POEM (peroral endoscopic myotomy) | |
| LHM | group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication) |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment success
treatment success is defined as an Eckardt Score </=3
Measured: 1 year after treatment
Secondary outcomes (6)
procedure related adverse events
retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure
Measured: 3 months after treatment
lower esophageal sphincter pressure (LESP)
retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure
Measured: 3 months after treatment
symptomatic reflux and use of antacid medication
retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure
Measured: 3 months after treatment
procedure related adverse events
retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure
Measured: 12 months after treatment
lower esophageal sphincter pressure (LESP)
retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure
Measured: 12 months after treatment
symptomatic reflux and use of antacid medication
retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: data income too low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Comparison of Short- Term Success Rates of POEM With LHMStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Collaborators
- Agaplesion Markus Krankenhaus, Johannes Gutenberg University Mainz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), McGill University, University Hospital, Zürich, Aarhus University Hospital
- Responsible party
- Principal investigator, Prof. Dr. Thomas Rösch, Universitätsklinikum Hamburg-Eppendorf
- Investigators
- Thomas Rösch, Prof. Dr., Principal investigator, University Hospital Eppendorf, Hamburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018705
- Sponsor's protocol ID
- PV4519
- Other IDs
- Ethics Committee, Hamburg
- Acronym
- POEM3
- Status last verified
- Jun 2019
- First submitted
- 17 Dec 2013
- Last updated
- 7 Jun 2019
- Results posted
- No
- Data monitoring committee
- 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 19106675Pasricha 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 20354937Zhou PH, Li QL, Yao LQ, Xu MD, Chen WF, Cai MY, Hu JW, Li L, Zhang YQ, Zhong YS, Ma LL, Qin WZ, Cui Z. Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. Endoscopy. 2013;45(3):161-6. doi: 10.1055/s-0032-1326203. Epub 2013 Feb 6.
PubMed 23389963von 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 22068665Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9.
PubMed 23665071Swanstrom 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 21996484Costamagna G, Marchese M, Familiari P, Tringali A, Inoue H, Perri V. Peroral endoscopic myotomy (POEM) for oesophageal achalasia: preliminary results in humans. Dig Liver Dis. 2012 Oct;44(10):827-32. doi: 10.1016/j.dld.2012.04.003. Epub 2012 May 19.
PubMed 22609465
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia, a Retrospective Multicenter Study
- ClinicalTrials.gov ID
- NCT02018705
- Acronym / sponsor ID
- POEM3 / PV4519
- Conditions
- Comparison of Short- Term Success Rates of POEM With LHM, Comparison of Long-term Success Rates of POEM With LHM
- Keywords
- POEM, LHM, Achalasia treatment, LES sphincter myotomy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: data income too low
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Collaborators
- Agaplesion Markus Krankenhaus, Johannes Gutenberg University Mainz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), McGill University, University Hospital, Zürich, Aarhus University Hospital
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Dec 2013 (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.
For the treatment of Achalasia, LHM has been the only surgical therapy. Recently, an endoscopic approach for this therapy has been developed (peroral endoscopic Myotomy POEM). Studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, long-term comparative data with LHM is required. Therefore,the intention for this study is to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.
Detailed description
Achalasia is a neurodegenerative esophageal motility disorder characterized by incomplete lower esophageal sphincter (LES) relaxation, increased LES tone, and aperistalsis of the esophagus. The standard surgical treatment for achalasia is laparoscopic Heller Myotomy (LHM). A recent meta-analysis of 105 studies reporting on 7855 patients demonstrated that laparoscopic Heller myotomy is the most effective and long-lasting therapy for achalasia. Superior to Endoscopic balloon dilatation or Botulinumtoxin injection LHM has a one year therapeutic efficacy in approximately 90% of patients. Recently an endoscopic technique emulating the principles of LHM was developed. This technique of a purely endoscopic myotomy has been demonstrated by Pasricha et al. in animal experiments and Inoue et al. reported the first clinical study. Other pilot studies and a larger international multi-center trial have replicated promising results for POEM.
Uncontrolled studies show promising short and mid term results for POEM. At present, POEM is considered a promising new technique with the potential to become a standard achalasia treatment. For this to happen, however, comparative data with LHM is required. Our study group intends to investigate the short and long-term efficacy of POEM for the treatment of achalasia as it was performed in international centers and compare outcomes with database assessment of LHM.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POEM | – | –group of Achalasia patients treated with POEM (peroral endoscopic myotomy) |
| LHM | – | –group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Achalasia patients who have been treated with either POEM or LHM
Key inclusion criteria (3 listed)
- Patients with symptomatic achalasia and pre-op barium swallow, manometry and oesophago-gastro-duodenoscopy which have been consistent with the diagnosis
- Age > 18 years with medical indication for interventional achalasia treatment
- Availability of Eckardt score at baseline and 12 months after initial treatment
Key exclusion criteria (12 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.
Primary outcome
treatment success
Time frame: 1 year after treatment
treatment success is defined as an Eckardt Score </=3
6 secondary outcomes
procedure related adverse events
Time frame: 3 months after treatment
lower esophageal sphincter pressure (LESP)
Time frame: 3 months after treatment
symptomatic reflux and use of antacid medication
Time frame: 3 months after treatment
procedure related adverse events
Time frame: 12 months after treatment
lower esophageal sphincter pressure (LESP)
Time frame: 12 months after treatment
symptomatic reflux and use of antacid medication
Time frame: 12 months after treatment
Results and safety
The study was stopped early (reason given: data income too low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- 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 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 23389963Zhou PH, Li QL, Yao LQ, Xu MD, Chen WF, Cai MY, Hu JW, Li L, Zhang YQ, Zhong YS, Ma LL, Qin WZ, Cui Z. Peroral endoscopic remyotomy for failed Heller myotomy: a prospective single-center study. Endoscopy. 2013;45(3):161-6. doi: 10.1055/s-0032-1326203. Epub 2013 Feb 6.
- 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 23665071Von Renteln D, Fuchs KH, Fockens P, Bauerfeind P, Vassiliou MC, Werner YB, Fried G, Breithaupt W, Heinrich H, Bredenoord AJ, Kersten JF, Verlaan T, Trevisonno M, Rosch T. Peroral endoscopic myotomy for the treatment of achalasia: an international prospective multicenter study. Gastroenterology. 2013 Aug;145(2):309-11.e1-3. doi: 10.1053/j.gastro.2013.04.057. Epub 2013 May 9.
- 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 22609465Costamagna G, Marchese M, Familiari P, Tringali A, Inoue H, Perri V. Peroral endoscopic myotomy (POEM) for oesophageal achalasia: preliminary results in humans. Dig Liver Dis. 2012 Oct;44(10):827-32. doi: 10.1016/j.dld.2012.04.003. Epub 2012 May 19.
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 Rösch, Prof. Dr. principal investigator
University Hospital Eppendorf, Hamburg
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparison of Short- Term Success Rates of POEM With LHM and Comparison of Long-term Success Rates of POEM With LHM, run by Universitätsklinikum Hamburg-Eppendorf at 5 sites in 4 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 12 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: stopped early, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Denmark, Netherlands, Switzerland. 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 was stopped early (reason given: data income too low). Results are not available in the source record.
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?
treatment success (time frame: 1 year 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 NCT02018705, which also lists 8 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 7 Jun 2019.