Status:
UNKNOWN
Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.
Lead Sponsor:
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborating Sponsors:
Centre of Postgraduate Medical Education
Conditions:
Zenker Diverticulum
Diverticulum, Esophago-Pharyngeal
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence...
Detailed Description
Participants will be randomized into one of two groups: (I) Z-POEM, (II) flexible endoscopic septotomy. Patients with clinical failure will be offered other method of treatment and will be included to...
Eligibility Criteria
Inclusion
- Males and females who are 18 years of age and older and are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF).
- Patients with symptomatic Zenker's Diverticulum.
- Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations.
- Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations.
Exclusion
- Lack of written consent for participation in the study.
- Size of Zenker's Diverticulum \<1,5 cm or \>4 cm on radiological examination.
- Active cancer.
- Esophageal stricture.
- Eosinophilic esophagitis (EoE).
- Pre-cancerous changes in the esophagus.
- Previous surgical or endoscopic treatment of Zenker's Diverticulum.
- Presence of chewing deficiencies and/or neurogenic dysphagia.
- Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility disorders.
- Severe systemic diseases which are contraindication to general sedation.
- Severe coagulopathy.
- Pregnancy and breastfeeding.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT04514042
Start Date
October 1 2020
End Date
December 1 2021
Last Update
August 14 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, Poland