POETA: Per Oral Endoscopic Myotomy (POEM) and Prolonged Dilatation (PRD) for Achalasia
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Per oral endoscopic therapy A Per oral endoscopic myotomy |
Procedure: Endoscopic intervention A
POEM: Per oral endoscopic myotomy
|
| Active Comparator: Per oral endoscopic therapy B Prolonged dilatation by implantation of large diameter stents. |
Procedure: Endoscopic intervention B
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
|
| Active Comparator: Per oral endoscopic therapy C Dilatation |
Procedure: Endoscopic intervention C
Endoscopic balloon dilatation
|
| Active Comparator: Laparoscopic surgery Laparoscopic Heller myotomy |
Procedure: Laparoscopic Surgery
Laparoscopic Heller myotomy
|
Outcome Measures
Primary Outcome Measures
- Achalasia specific symptoms according to the Eckardt score (0-12) [6 mo post-op]
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)
Secondary Outcome Measures
- Barium column height (cm) in esophagogram [6 mo post-op]
- Resting pressure (mmHg) at the lower esophageal sphincter [6 mo post-op]
- Stent migration [p.o. day 1]
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.
- Percent of time (min)/24h that the pH is less than 4.0 in pH-metry [6 mo post-op]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Confirmed diagnosis of achalsia, hypertensive lower esophageal sphincter, nutcracker esophagus, or diffuse esophageal spasm
Exclusion Criteria:
- Contraindication for EGD
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, Medical University of Vienna | Vienna | Austria | 1090 |
Sponsors and Collaborators
- Medical University of Vienna
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- POETA