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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Per oral endoscopic therapy A | Active Comparator | Per oral endoscopic myotomy |
|
| Per oral endoscopic therapy B | Active Comparator | Prolonged dilatation by implantation of large diameter stents. |
|
| Per oral endoscopic therapy C | Active Comparator | Dilatation |
|
| Laparoscopic surgery | Active Comparator | Laparoscopic Heller myotomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic intervention A | Procedure | POEM: Per oral endoscopic myotomy |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Department of Surgery, Medical University of Vienna | Contact | +43 1 40400 | 5621 | sebastian.schoppmann@meduniwien.ac.at; erwin.rieder@meduniwien.ac.at |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Medical University of Vienna | Recruiting | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D004931 | Esophageal Achalasia |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D010535 | Laparoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Endoscopic intervention B |
| Procedure |
PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options. |
|
| Endoscopic intervention C | Procedure | Endoscopic balloon dilatation |
|
| Laparoscopic Surgery | Procedure | Laparoscopic Heller myotomy |
|
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 |
| D004066 | Digestive System Diseases |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |