An observational study in Comparison of Short- Term Success Rates of POEM With LHM and Comparison of Long-term Success Rates of POEM With LHM, sponsored by Universitätsklinikum Hamburg-Eppendorf. Terminated at 5 sites in 4 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-07.
Sponsored by Universitätsklinikum Hamburg-Eppendorf · Observational
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.
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.
140 studies on the registry are indexed under Esophageal Achalasia; 44 are open to participants now.
This study's enrollment of 47 is below the median of 111 across 41 observational studies indexed under Esophageal Achalasia.
Browse Esophageal Achalasia studies →Universitätsklinikum Hamburg-Eppendorf is the lead sponsor of 403 studies on the registry; 83 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Achalasia patients who have been treated with either POEM or LHM
Exclusion Criteria:
group of Achalasia patients treated with POEM (peroral endoscopic myotomy)
group of Achalasia patients treated with LHM (laparoscopic Heller myotomy)(+ fundoplication)
treatment success
treatment success is defined as an Eckardt Score \</=3
Time frame: 1 year after treatment
procedure related adverse events
retrospective data for this timepoint can be used of the interval 2-8 months after the initial procedure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after treatment
any reported GERD data
Time frame: procedure to five years after treatment
duration of procedure
duration of procedure (minutes)
Time frame: procedure
in-hospital stay
in-hospital stay of patients (days)
Time frame: procedure
length of myotomy
length of myotomy (centimeters)
Time frame: procedure
procedure related complications
any complication during performance of treatment that required conversion to either laparoscopic (POEM) or open surgical treatment
Time frame: procedure
This study is terminated, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Universitätsklinikum Hamburg-Eppendorf