Zenker Diverticulum
Conditions
Keywords
Zenker's diverticulum, Z-POEM, Diverticuloscope, Knife Septotomy, Clutch Cutter
Brief summary
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
PROCEDUREEndoscopic diverticulotomy with Z-POEM
Endoscopic diverticulotomy with Z-POEM
PROCEDUREEndoscopic diverticulotomy using a non-tunnelization technique
Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter
Sponsors
Société Française d'Endoscopie Digestive
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum. | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical success rate after endoscopic treatment. | 3 months | Clinical success is assessed using the Augsburg scale, with a score \<5. |
| Variation in Augsburg score at different time points | 3 months, 6 months, 12 months, and 24 months | comparing the Augsburg scores at each time point with baseline data for each patient. |
| Complication rate associated with the endoscopic procedure | 15 days | 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 |
| Radiographic resolution rate of the diverticulum | 3 months | 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%. |
| Symptomatic Recurrence Rate Post-Treatment: | at 3, 6, 12, and 24 Months | 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. |
Contacts
Primary ContactBertrand BRIEAU, MD
Backup ContactMaira MORENO, PhD
Outcome results
None listed