Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia

Study Overview
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Brief Summary
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Achalasia is an esophageal motility disorder, which leads to clinical symptoms such as dysphagia, regurgitation, chest pain and consecutive weight loss. Although conventional treatment such as laparoscopic Heller myotomy (LHM) and balloon dilatation (BD) can provide sufficient symptom relief in many patients, both interventions have their individual drawbacks. Additionally, treatment after failed LHM or BD can be challenging and in few might even lead to esophagectomy. Per oral endoscopic myotomy (POEM) and prolonged dilatation (PRD) are two novel endoscopically performed therapeutic options for achalasia and other esophageal motility disorders. Both not only appear to provide good results, when performed as initial treatment but also might be an excellent option after e.g failed LHM. The purpose of this study is to evaluate the long-term efficacy of four different treatment options, such as POEM, PRD with stent-fixation, PD and conventional LHM for achalasia in an individualized treatment setting.

Official Title
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Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) as Additional Endoscopic Treatment Options for Achalasia and Other Esophageal Motility Disorders

Conditions
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Esophageal Achalasia

Intervention / Treatment
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* Procedure: Endoscopic intervention A
* Procedure: Endoscopic intervention B
* Procedure: Endoscopic intervention C
* Procedure: Laparoscopic Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm Exclusion Criteria: Contraindication for EGD

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Per oral endoscopic therapy A<br>Per oral endoscopic myotomy | Procedure: Endoscopic intervention A<br>* POEM: Per oral endoscopic myotomy<br>|
| Active Comparator: Per oral endoscopic therapy B<br>Prolonged dilatation by implantation of large diameter stents. | Procedure: Endoscopic intervention B<br>* PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.<br>|
| Active Comparator: Per oral endoscopic therapy C<br>Dilatation | Procedure: Endoscopic intervention C<br>* Endoscopic balloon dilatation<br>|
| Active Comparator: Laparoscopic surgery<br>Laparoscopic Heller myotomy | Procedure: Laparoscopic Surgery<br>* Laparoscopic Heller myotomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achalasia specific symptoms according to the Eckardt score (0-12) | Eckardt score: Weight loss 0kg (0), less than 5kg (1), 5-10 kg (2), more than 10 kg (3); Dysphagia none(0), occasional (1), daily (2), every meal (3); Regurgitation none(0), occasional (1), daily (2), every meal (3); Retrosternal pain none(0), occasional (1), daily (2), every meal (3) | 6 mo post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Barium column height (cm) in esophagogram |  | 6 mo post-op | 
| Resting pressure (mmHg) at the lower esophageal sphincter |  | 6 mo post-op | 
| Stent migration | Analysis: On the first postoperative day a routine esophagogram will be used to evaluate the appropriate location of the esophageal stent. Early distal stent dislocation/migration into the stomach will be registered. | p.o. day 1 | 
| Percent of time (min)/24h that the pH is less than 4.0 in pH-metry |  | 6 mo post-op |