Endoscopic Treatment for Zenker's Diverticulum

Recruiting

• Conditions: Zenker Diverticulum

• Registration Number: NCT03948438
• Lead Sponsor: Istituto Clinico Humanitas

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-14
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2028-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria

• pregnancy and breastfeeding

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	24 hours after the procedure	Any complications as bleeding, perforation, others

Secondary Outcome Measures

Name	Time	Method
symptoms after the procedure	up to 5 years	The frequency of symptoms such as dysphagia, regurgitation, weight loss

Trial Locations

Locations (1)

Humanitas Research Hospital; 🇮🇹 Rozzano, Italy