Pneumodilation Or Endoscopic Myotomy in Achalasia (POEMA) Trial.
- Conditions
- Achalasia, Pneumodilation, Per-Oral Endoscopic Myotomy (POEM)
- Registration Number
- NL-OMON21319
- Lead Sponsor
- AMC Amsterdam (University Medical Centre)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 130
Inclusion Criteria
1. Presence of achalasia, as shown on oesophageal manometry;
2. Eckardt score > 3;
Exclusion Criteria
1. Previous endoscopic or surgical treatment for achalasia, except botulinium toxin injections;
2. Previous surgery of the stomach or oesophagus;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is treatment succes, defined as:<br /><br>1. An Eckardt score of 3 or less;<br /><br>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;<br /><br>3. The absence of severe complications<br>associated with treatment.
- Secondary Outcome Measures
Name Time Method 1. Quality of life and achalasia-specific quality of life;<br /><br>2. Stasis in the oesophagus, measured with a timed barium oesophagogram;<br /><br>3. Presence of reflux symptoms, reflux oesophagitis and excessive oesophageal acid exposure;<br /><br>4. Lower oesophageal sphincter pressure and integrative relaxation pressure (IRP4), as measured with high-resolution manometry;<br /><br>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”;<br /><br>6. The need for endoscopic or surgical retreatment after the initial treatment session.