Endoscopic Treatment for Zenker's Diverticulum
Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
1 other identifier
observational
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 8, 2019
CompletedFirst Posted
Study publicly available on registry
May 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
September 21, 2022
September 1, 2022
20 years
May 8, 2019
September 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of Adverse Events
Any complications as bleeding, perforation, others
24 hours after the procedure
Secondary Outcomes (1)
symptoms after the procedure
up to 5 years
Interventions
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)
Eligibility Criteria
patients affected by ZD and treated by endoscopic procedures.
You may qualify if:
- patients with symptomatic ZD treated by endoscopic procedures
You may not qualify if:
- pregnancy and breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Humanitas Research Hospital
Rozzano, 20089, Italy
Related Publications (1)
Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.
PMID: 34236338DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 8, 2019
First Posted
May 14, 2019
Study Start
January 1, 2009
Primary Completion (Estimated)
December 30, 2028
Study Completion (Estimated)
December 30, 2028
Last Updated
September 21, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share