Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

NCT ID: NCT06594718

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 128 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2028-10-31

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.

Conditions

Zenker Diverticulum

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Endoscopic treatment with (Z-POEM)

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

Endoscopic diverticulotomy with Z-POEM

Intervention Type: PROCEDURE

Endoscopic diverticulotomy with Z-POEM

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.

Endoscopic diverticulotomy using a non-tunnelization technique

Intervention Type: PROCEDURE

Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter

Interventions

Endoscopic diverticulotomy with Z-POEM

Endoscopic diverticulotomy with Z-POEM

Intervention Type: PROCEDURE

Endoscopic diverticulotomy using a non-tunnelization technique

Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Société Française d'Endoscopie Digestive

OTHER

Sponsor Role: lead

Responsible Party

Bertrand Brieau

Medical doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Bertrand BRIEAU, MD

Role: CONTACT

bertrand.brieau@gmail.com

+33 650266383

Maira MORENO, PhD

Role: CONTACT

rechercheclinique@sfed.org

+33 472117513

Other Identifiers

SFED 157

Identifier Type: -

Identifier Source: org_study_id