NCT03948438

Endoscopic Treatment for Zenker's Diverticulum

Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 400 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Zenker Diverticulum

Interventions

Type	Name	Description
PROCEDURE	Endoscopic septotomy	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)

Timeline

• Start date: 2009-01-01
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2019-05-14
• Last updated: 2022-09-21

Locations

1 site across 1 country: Italy