An observational study in Zenker Diverticulum, sponsored by Société Française d'Endoscopie Digestive. Not yet recruiting. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Société Française d'Endoscopie Digestive · Observational
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.
Société Française d'Endoscopie Digestive is the lead sponsor of 25 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone.
Procedure: Endoscopic diverticulotomy with Z-POEM
Patients undergoing a peroral endoscopic myotomy using a no-tunneling method (Diverticuloscope, Knife Septotomy, and Clutch Cutter) to access the target zone.
Procedure: Endoscopic diverticulotomy using a non-tunnelization technique
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%.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2024; primary completion for Oct 2028, 48 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Zenker Diverticulum
Société Française d'Endoscopie Digestive