This trial is active, not recruiting.

Condition achalasia
Treatments peroral endoscopic myotomy (poem), laparoscopic heller myotomy (lhm)
Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborator Klinikum Augsburg
Start date December 2013
End date December 2015
Trial size 240 participants
Trial identifier NCT01601678, POEM rcpmt


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the POEM therapy group
peroral endoscopic myotomy (poem)
Endoluminal submucosal myotomy of the distal esophagus/lower esophageal sphincter for treatment of achalasia(see Inoue et al. Endoscopy 2010) POEM procedure steps: Lavage, entry point 12-14cm above GEJ at the lesser curvature site, Inject 10ml saline with methylene blue, create 2cm entry point, advance endoscope into the submucosa, repeated submucosal injection and dissection of the submucosal tunnel up to 2-3cm into the cardia, dissect the submucosa close to the muscularis with repeated checks endoluminally, after completion of the submucosal tunnel flush with gentamycin, perform myotomy from proximal to distal starting 4-5cm below the entry point down to at least 2cm onto the cardia, after complete myotomy check for mucosal integrity, close the entry point with clips from distal to proximal
(Active Comparator)
Patients with Achalasia, designated to receive a myotomy of the lower esophageal sphincter, who have been randomised into the LHM therapy group.
laparoscopic heller myotomy (lhm)
laparoscopic myotomy of the lower esophageal sphincter as with standard achalasia therapy: after opening the phren-oesophageal ligament to mobilise distal esophagus distally and proximally, a 1.5- 2cm myotomy at the cardia with an approximately 6-8cm myotomy extension into the distal esophagus is made. As anti reflux procedure, a Dor hemifundoplication is preferred

Primary Outcomes

non-inferiority of POEM compared to LHM
time frame: 2 years after treatment

Secondary Outcomes

Eckhard symptom scores
time frame: before,and 3 and 6 months, 1,3 and 5 years past procedure
reflux symptom assessment
time frame: before, and 3 and 6 months, and 1, 2, 3, and 5 years post procedure
Life Quality index
time frame: before, and 3 months, and 2 and 5 years post procedure
pH metry
time frame: 3 months and (optional) 2 and 5 years after therapy
EGD findings
time frame: 3 months and (optional) 2 and 5 years after therapy
complication rate
time frame: Baseline to five years past procedure
Lower esophageal sphincter pressure (LESP)
time frame: before, and 3 months, and 2 and 5 years post procedure

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patient with symptomatic achalasia and pre-op barium swallow, manometry and esophagogastroduodenoscopy which are consistent with the diagnosis - Persons of age > 18 years with medical indication for surgical myotomy or EBD - Signed written informed consent Exclusion Criteria: - Patients with previous surgery of the stomach or esophagus - Patients with known coagulopathy - Previous achalasia treatment with surgery - Patients with liver cirrhosis and/or esophageal varices - Active esophagitis - Eosinophilic esophagitis - Severe Candida esophagitis - Barrett's esophagus - Pregnancy - Stricture of the esophagus - Malignant or premalignant esophageal lesion - Hiatal hernia > 1cm

Additional Information

Official title Endoscopic Versus Laparoscopic Myotomy for Treatment of Idiopathic Achalasia: A Randomized, Controlled Trial
Principal investigator Helmut Messmann, Prof.
Description Peroral Endoscopic Myotomy myotomy (POEM) has been recently introduced for treatment of achalasia, based on technical developments from NOTES (natural orifice translumenal surgery). The technique uses a submucosal esophageal tunnel through which a distal esophageal myotomy down to the proximal stomach is performed. Single center studies demonstrate promising short-term results of POEM for the treatment of achalasia, leading us to hope for a similar success rate along with reduced patient discomfort. For POEM to be integrated inot clinical routine, comparative data regarding safety and efficacy are necessary. This study intends to investigate the feasibility, safety and efficacy of Peroral Endoscopic Myotomy (POEM)for the treatment of achalasia compared to laparoscopic surgical therapy (laparoscopic Heller Myotomy)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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Universitätsklinikum Hamburg-Eppendorf.