PLOS ONE · 12 authors, 7 centres
This summary was generated by AI from a single paper. It has not been reviewed by a clinician and is not clinical advice. Verify against the source before acting on it.
This is a protocol for a multicenter randomized controlled trial comparing two endoscopic treatments, peroral endoscopic myotomy (POEM) and endoscopic balloon dilation (EBD), for achalasia in children. The primary outcome will be the need for retreatment due to treatment failure within 12 months.
This paper presents a protocol for an international, multicenter, randomized controlled trial comparing peroral endoscopic myotomy (POEM) to endoscopic balloon dilation (EBD) as primary treatment for achalasia in children. The trial will use a blinded endpoint committee to assess the primary outcome, defined as the need for retreatment within 12 months due to persisting symptoms (Eckardt score > 3) with evidence of recurrence on barium swallow or high-resolution manometry. Adverse events will be recorded and an independent Data Safety Monitoring Board will evaluate safety after 50 participants complete one year of follow-up. This trial is intended to provide the first prospective, randomized evidence on the comparative effectiveness and safety of these endoscopic therapies for treatment-naïve pediatric patients.
