An observational study in Zenker Diverticulum, sponsored by Istituto Clinico Humanitas. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-21.
Sponsored by Istituto Clinico Humanitas · Observational
Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.
Istituto Clinico Humanitas is the lead sponsor of 279 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients affected by ZD and treated by endoscopic procedures.
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Exclusion Criteria:
Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)
Incidence of Adverse Events
Any complications as bleeding, perforation, others
Time frame: 24 hours after the procedure
symptoms after the procedure
The frequency of symptoms such as dysphagia, regurgitation, weight loss
Time frame: up to 5 years
Plan to share: No
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Zenker Diverticulum