Endoscopic Treatment for Zenker's Diverticulum

ConditionZenker Diverticulum

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIstituto Clinico Humanitas

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

patients with symptomatic ZD treated by endoscopic procedures

Disqualifiers

pregnancy and breastfeeding

Trial population

patients affected by ZD and treated by endoscopic procedures.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Endoscopic septotomy
Procedure/Surgery
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)

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

Incidence of Adverse Events

Any complications as bleeding, perforation, others

Time frame

24 hours after the procedure

Secondary outcomes

symptoms after the procedure

The frequency of symptoms such as dysphagia, regurgitation, weight loss

Time frame

up to 5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Clinico Humanitas

Lead sponsor

Source ClinicalTrials.gov

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