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.
Study Type
OBSERVATIONAL
Enrollment
128
Endoscopic diverticulotomy with Z-POEM
Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter
Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.
Symptomatic recurrence is defined by: Clinical resolution after endoscopic treatment, as assessed clinically at 3 months, with an Augsburg score \<5. Reappearance of clinical symptoms, following clinical resolution after endoscopic treatment, with an Augsburg score ≥5.
Time frame: 12 months
Clinical success rate after endoscopic treatment.
Clinical success is assessed using the Augsburg scale, with a score \<5.
Time frame: 3 months
Variation in Augsburg score at different time points
comparing the Augsburg scores at each time point with baseline data for each patient.
Time frame: 3 months, 6 months, 12 months, and 24 months
Complication rate associated with the endoscopic procedure
Number of patients with at least one of the following complications: Pneumoperitoneum insufflation, Fever during hospitalization (T \> 38.5°C), Post-procedure hemorrhage, Post-procedure antibiotic therapy, Post-procedure scan, Intensive care unit/rehabilitation hospitalization, or Surgery for complications
Time frame: 15 days
Radiographic resolution rate of the diverticulum
Radiographic resolution rate of the diverticulum, assessed by a TOGD (barium swallow) at 3 months: Radiographic resolution is defined by a reduction in the diverticulum's volume between the preoperative TOGD and the TOGD at 3 months. The volume is estimated from the millimeter measurements of the diverticulum in its craniocaudal, anteroposterior, and laterolateral dimensions. The definitions are as follows: Complete resolution: Complete disappearance of the diverticulum. Partial resolution: Reduction in diverticular volume of at least 50%. Minor resolution: Reduction in diverticular volume between 20% and 50%. No resolution: Reduction in diverticular volume \< 20%.
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Time frame: 3 months
Symptomatic Recurrence Rate Post-Treatment:
Number of patients with symptomatic recurrence, defined as the reappearance of clinical symptoms at 3, 6, 12, and 24 months after endoscopic treatment, with an Augsburg score of ≥5.
Time frame: at 3, 6, 12, and 24 Months