Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endoscopic diverticulotomy with Z-POEM, Endoscopic diverticulotomy using a non-tunnelization technique.
- Who it may be relevant to
- Registry conditions: Zenker Diverticulum. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques
Overview
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.
Interventions
- Procedure Endoscopic diverticulotomy with Z-POEM
Endoscopic diverticulotomy with Z-POEM - Procedure Endoscopic diverticulotomy using a non-tunnelization technique
Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter
Primary outcome measures
- Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum. [Time frame: 12 months]
Secondary outcome measures (5)
- Clinical success rate after endoscopic treatment. [Time frame: 3 months]
- Variation in Augsburg score at different time points [Time frame: 3 months, 6 months, 12 months, and 24 months]
- Complication rate associated with the endoscopic procedure [Time frame: 15 days]
- Radiographic resolution rate of the diverticulum [Time frame: 3 months]
- Symptomatic Recurrence Rate Post-Treatment: [Time frame: at 3, 6, 12, and 24 Months]
Eligibility criteria
Inclusion criteria
- 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
- No participation in another concurrent clinical study
Exclusion criteria
- 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.
- Patient who has already undergone initial endoscopic or surgical treatment for Zenker's diverticulum
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06594718 · SFED 157