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NCT Number: NCT06594718

Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

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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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic diverticulotomy with Z-POEM

Procedure

Endoscopic diverticulotomy with Z-POEM

Endoscopic diverticulotomy using a non-tunnelization technique

Procedure

Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter

Primary outcomes

  1. Symptomatic recurrence rate after endoscopic tunnelization therapy (Z-POEM) compared to non-tunnelization techniques in patients with symptomatic Zenker's diverticulum.

    Time frame: 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 outcomes

  1. Clinical success rate after endoscopic treatment.

    Time frame: 3 months

    Clinical success is assessed using the Augsburg scale, with a score <5.

  2. Variation in Augsburg score at different time points

    Time frame: 3 months, 6 months, 12 months, and 24 months

    comparing the Augsburg scores at each time point with baseline data for each patient.

  3. Complication rate associated with the endoscopic procedure

    Time frame: 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

  4. Radiographic resolution rate of the diverticulum

    Time frame: 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%.

  5. Symptomatic Recurrence Rate Post-Treatment:

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand BRIEAU, MD

CONTACT

[email protected]

+33 650266383

Maira MORENO, PhD

CONTACT

[email protected]

+33 472117513

Sponsors and collaborators

Lead sponsor

Société Française d'Endoscopie Digestive

Other

Registry information

Official study title

Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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