Zenker Diverticulum
Conditions
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.
Interventions
PROCEDUREEndoscopic 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)
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* patients with symptomatic ZD treated by endoscopic procedures
Exclusion criteria
* pregnancy and breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 24 hours after the procedure | Any complications as bleeding, perforation, others |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| symptoms after the procedure | up to 5 years | The frequency of symptoms such as dysphagia, regurgitation, weight loss |
Countries
Italy
Contacts
Primary ContactAlessandro Repici, Prof.
Outcome results
None listed