Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

Not yet recruiting

• Conditions: Zenker Diverticulum
• Interventions: Procedure: Endoscopic diverticulotomy with Z-POEM; Procedure: Endoscopic diverticulotomy using a non-tunnelization technique

• Registration Number: NCT06594718
• Lead Sponsor: Société Française d'Endoscopie Digestive

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-10
• Last Update Submitted: 2024-09-10
• Study First Posted: 2024-09-13
• Last Update Posted: 2024-09-13
• Study Start: 2024-10-31
• Primary Completion: 2028-10-31
• Study Completion: 2028-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endoscopic treatment with (Z-POEM)	Endoscopic diverticulotomy 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	Endoscopic diverticulotomy 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.