Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

Société Française d'Endoscopie Digestive

Status: Not yet enrolling

Conditions: Zenker Diverticulum

Treatments: Procedure: Endoscopic diverticulotomy using a non-tunnelization technique; Procedure: Endoscopic diverticulotomy with Z-POEM

Study type: Observational

Funder types: Other

Identifiers

NCT06594718

SFED 157

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

128 participants in 2 patient groups

Endoscopic treatment with (Z-POEM)

Description:

Patients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone.

Treatment:

Procedure: Endoscopic diverticulotomy with Z-POEM

Endoscopic treatment using a non-tunnelization technique

Description:

Patients undergoing a peroral endoscopic myotomy using a no-tunneling method (Diverticuloscope, Knife Septotomy, and Clutch Cutter) to access the target zone.

Treatment:

Procedure: Endoscopic diverticulotomy using a non-tunnelization technique