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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic treatment with (Z-POEM) | Patients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone. |
| |
| Endoscopic treatment using a non-tunnelization technique | Patients undergoing a peroral endoscopic myotomy using a no-tunneling method (Diverticuloscope, Knife Septotomy, and Clutch Cutter) to access the target zone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic diverticulotomy with Z-POEM | Procedure | Endoscopic diverticulotomy with Z-POEM |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical success rate after endoscopic treatment. | Clinical success is assessed using the Augsburg scale, with a score <5. | 3 months |
| Variation in Augsburg score at different time points | comparing the Augsburg scores at each time point with baseline data for each patient. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertrand BRIEAU, MD | Contact | +33 650266383 | bertrand.brieau@gmail.com | |
| Maira MORENO, PhD | Contact | +33 472117513 | rechercheclinique@sfed.org |
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| ID | Term |
|---|---|
| D016672 | Zenker Diverticulum |
| ID | Term |
|---|---|
| D004936 | Diverticulum, Esophageal |
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
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| Endoscopic diverticulotomy using a non-tunnelization technique | Procedure | Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter |
|
| 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 | 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%. | 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. | at 3, 6, 12, and 24 Months |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |