Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

NCT06594718 | Not Yet Recruiting

• 1 other identifier: SFED 157
• Study Type: observational
• Target: 128
• Locations: 0 countries
• Sites: N/A

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

Keywords

Zenker's diverticulum; Z-POEM; Diverticuloscope; Knife Septotomy; Clutch Cutter

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Clinical success rate after endoscopic treatment.

  3 months

• Variation in Augsburg score at different time points

  3 months, 6 months, 12 months, and 24 months

• Complication rate associated with the endoscopic procedure

  15 days

• Radiographic resolution rate of the diverticulum

  3 months

• Symptomatic Recurrence Rate Post-Treatment:

  at 3, 6, 12, and 24 Months

Study Arms (2)

Endoscopic treatment with (Z-POEM)

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

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.

Procedure: Endoscopic diverticulotomy using a non-tunnelization technique

Interventions

Endoscopic diverticulotomy with Z-POEM PROCEDURE

Endoscopic diverticulotomy with Z-POEM

Endoscopic treatment with (Z-POEM)

Endoscopic diverticulotomy using a non-tunnelization technique PROCEDURE

Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter

Endoscopic treatment using a non-tunnelization technique

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Société Française d'Endoscopie Digestive: lead

MeSH Terms

Conditions

Zenker Diverticulum

Condition Hierarchy (Ancestors)

Diverticulum, Esophageal; Diverticulum; Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bertrand BRIEAU, MD

CONTACT

+33 650266383; bertrand.brieau@gmail.com

Maira MORENO, PhD

CONTACT

+33 472117513; rechercheclinique@sfed.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor, Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: October 31, 2024
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share