Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)
ConditionZenker Diverticulum
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSociété Française d'Endoscopie Digestive
About this trial
Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. This is a prospective, comparative, observational, multicenter study with the primary objective of comparing the symptomatic recurrence rate one year after endoscopic tunnelization therapy (Z-POEM) versus non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
Eligibility criteria
Qualifiers
Patients with symptomatic Zenker's diverticulum (Augsburg score ≥5 )
Diagnostic evaluation including esophagogastroduodenoscopy (EGD) and a barium swallow (TOGD) with measurement of the diverticulum's height.
Patient aged 18 years or older
Patient with ASA 1, ASA 2, ASA 3 status
Disqualifiers
Patient under 18 years old
Patient with ASA 4 or ASA 5 status
Pregnant woman
Patient with coagulation disorders preventing the performance a polypectomy: PT < 50%, Platelets < 50,000/mm³, ongoing effective anticoagulation, or current clopidogrel use.
Trial design
Treatments tested in this trial
- Endoscopic diverticulotomy with Z-POEM
- Endoscopic diverticulotomy using a non-tunnelization technique
Treatment groups
128 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov