Health TrialsbyHealthPanel

Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)

ConditionZenker Diverticulum
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-90
SponsorSociété Française d'Endoscopie Digestive

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endoscopic diverticulotomy with Z-POEM

    Procedure/Surgery

    Endoscopic diverticulotomy with Z-POEM

  • Endoscopic diverticulotomy using a non-tunnelization technique

    Procedure/Surgery

    Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Endoscopic treatment with (Z-POEM)1 intervention
Group B: Endoscopic treatment using a non-tunnelization technique1 intervention

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

Clinical success rate after endoscopic treatment.

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

Time frame
3 months
2

Variation in Augsburg score at different time points

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

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

Complication rate associated with the endoscopic procedure

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

Time frame
15 days
4

Radiographic resolution rate of the diverticulum

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%.

Time frame
3 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Société Française d'Endoscopie Digestive

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: