Pneumodilation versus Per-Oral Endoscopic Myotomy in Achalasia patients with recurrent symptoms after Laparoscopic Heller Myotomy
- Conditions
- achalasiaPer-oral endoscopic myotomyRelapsePneumodilationSecondary treatmentLaparoscopic Heller Myotomy
- Registration Number
- NL-OMON25721
- Lead Sponsor
- Academic Medical Center (AMC) Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 45
Inclusion Criteria
1.Presence of achalasia as shown on oesophageal manometry at least once
2.Previous Heller myotomy
Exclusion Criteria
1.Previous pneumodilations after the Heller myotomy (pneumodilations before the Heller myotomy are allowed)
2.Previous (attempt at) POEM
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Treatment success at one year, defined as:<br>An Eckardt score of 3 or less in the absence of additional retreatment after the allocated treatment (patients in the pneumodilation arm undergo 2 pneumodilations, with 30 and 35 mm and another one or two pneumodilations are allowing up to 40 mm in case of symptom recurrence within 1 year), patients in the POEM arm undergo POEM and no subsequent treatments) <br>
- Secondary Outcome Measures
Name Time Method •Quality of life and achalasia-specific quality of life <br /><br>•Stasis in the oesophagus, measured with a timed barium oesophagogram <br /><br>•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>•Treatment success after two and five years follow up <br /><br>•The use of acid-suppressant drugs and the presence of reflux symptoms using the GerdQ questionnaire<br><br /> •The presence of reflux oesophagitis, as observed during upper endoscopy<br>