Comparison of Peroral Endoscopic Myotomy (POEM) With Laparoscopic Heller Myotomy (LHM) for Treatment of Achalasia

Terminated

• Conditions: Comparison of Long-term Success Rates of POEM With LHM; Comparison of Short- Term Success Rates of POEM With LHM

• Registration Number: NCT02018705
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

Brief 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. 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 Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-23
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-05
• Last Update Posted: 2019-06-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
treatment success	1 year after treatment	treatment success is defined as an Eckardt Score \</=3

Secondary Outcome Measures

Name	Time	Method
lower esophageal sphincter pressure (LESP)	12 months after treatment	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure
procedure related adverse events	12 months after treatment	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure
symptomatic reflux and use of antacid medication	12 months after treatment	retrospective data for this timepoint can be used of the interval 9-15 months after the initial procedure

Trial Locations

Locations (5)

University Hospital Eppendorf; 🇩🇪 Hamburg, Germany

University Medical Center; 🇩🇪 Mainz, Germany

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

University Hospital; 🇨🇭 Zürich, Switzerland

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark