The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Patients have a significantly reduced quality of life index and numerous complications. Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques. There is a novel technique, called the peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum. The ZIPPY trial designed as prospective, international, multicenter, double-blind, randomized study which will be carried out by experienced endoscopists. The aim of this study will be to evaluate the results of Zenker's diverticulum treatment using peroral endoscopic myotomy and to compare its efficacy and safety to flexible endoscopy septotomy. Patients at least 18 years old with symptomatic Zenker's diverticulum diagnosed on the basis of endoscopic and radiological examinations will be enrolled.
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Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
Timeframe: 3 Months
Rate of short-term clinical success defined as complete or near complete resolution of postprocedure dysphagia and other related symptoms (regurgitation, halitosis, cough, hoarseness, weight loss, episodes of aspiration pneumonia).
Timeframe: 3 Months