Achalasia, Pneumodilation, Per-Oral Endoscopic Myotomy (POEM)
Conditions
Interventions
Therapy-naive patients with idiopathic achalasia will undergo per-oral endoscopic myotomy (POEM) or pneumodilation, depend on the randomization. The POEM will be performed in one procedure. For the pn
2. Upper Endoscopy
3. Timed barium oesophagography
4. High Resolution Manometry (HRM)
5. pH-impedance monitoring
6. Questionnaires (SF-36, Achalasia-DSQoL, GerdQ and Eckardt score).
Sponsors
AMC Amsterdam (University Medical Centre)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Presence of achalasia, as shown on oesophageal manometry; 2. Eckardt score > 3; 3. Age between 18-80 years; 4. Signed written informed consent; 5. ASA class I or II.
Exclusion criteria
Exclusion criteria: 1. Previous endoscopic or surgical treatment for achalasia, except botulinium toxin injections; 2. Previous surgery of the stomach or oesophagus; 3. Known coagulopathy; 4. Presence of liver cirrhosis and/or oesophageal varices; 5. Presence of eosinophilic oesophagitis; 6. Presence of Barrett’s oesophagus; 7. Pregnancy at time of treatment; 8. Presence of a stricture of the oesophagus; 9. Presence of malignant or premalignant oesophageal lesions; 10. Presence of an extremely dilated oesophageal body (>6cm).
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life and achalasia-specific quality of life; 2. Stasis in the oesophagus, measured with a timed barium oesophagogram; 3. Presence of reflux symptoms, reflux oesophagitis and excessive oesophageal acid exposure; 4. Lower oesophageal sphincter pressure and integrative relaxation pressure (IRP4), as measured with high-resolution manometry; 5. Complications of the treatment, defined as any unwanted events that arise following treatment and/or that are secondary to the treatment. Complications are classified as “severe” when these result in admission > 24 hours or prolongation of an already planned admission of >24 hours, admission to a medium or intensive care unit, additional endoscopic procedures, or blood transfusion or death. Other complications are classified as “mild”; 6. The need for endoscopic or surgical retreatment after the initial treatment session. | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is treatment succes, defined as: 1. An Eckardt score of 3 or less; 2. The absence of the need for endoscopic or surgical retreatment in the period between the first treatment session (first and optional second dilation within first 3 months) and the endpoint; 3. The absence of severe complications associated with treatment. | — |
Contacts
Public ContactA.J. Bredenoord
Meibergdreef 9
Outcome results
None listed