Dysphagia Clinical Trial
Official title:
Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy: International, Multicentre, Randomized, Double-blind Clinical Trial.
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.
Participants will be randomized into one of two groups: (I) Z-POEM, (II) flexible endoscopic septotomy. Patients with clinical failure will be offered other method of treatment and will be included to observational cohort. The study has been approved by a local bioethics committee ;
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