Endoscopic Treatment for Zenker's Diverticulum

Zenker Diverticulum Clinical Trial

Official title:

Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03948438
• Other study ID #: ICH Zenker
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: December 30, 2028

Study information

• Verified date: September 2022
• Source: Istituto Clinico Humanitas
• Contact: Alessandro Repici, Prof.
• Email: alessandro.repici[@]hunimed.eu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 30, 2028
• Est. primary completion date: December 30, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

• pregnancy and breastfeeding

Related Conditions & MeSH terms

• Diverticulum
• Zenker Diverticulum

Intervention

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)

Locations

Country	Name	City	State
Italy	Humanitas Research Hospital	Rozzano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	Any complications as bleeding, perforation, others	24 hours after the procedure
Secondary	symptoms after the procedure	The frequency of symptoms such as dysphagia, regurgitation, weight loss	up to 5 years