Zenker DiverticulumNCT06594718
Endoscopic Treatment of Zenker's Diverticulum (ZENKTUN)
An observational study of Zenker Diverticulum, run by Société Française d'Endoscopie Digestive.
Trial summary
Prospective comparative observational study in numerous reference centers in France, comparing Tunnelization (Z-POEM) versus Non-Tunnelization Techniques according to the usual practices. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Zenker Diverticulum
- What is being tested?
- Endoscopic diverticulotomy with Z-POEM and Endoscopic diverticulotomy using a non-tunnelization technique
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 31 Oct 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques
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
- Being tested
- Endoscopic diverticulotomy with Z-POEM, Endoscopic diverticulotomy using a non-tunnelization technique
- Keywords
- Zenker's diverticulum, Z-POEM, Diverticuloscope, Knife Septotomy, Clutch Cutter
- Medical subject headings
- Zenker Diverticulum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic diverticulotomy with Z-POEMProcedure or surgery
Endoscopic diverticulotomy with Z-POEM
Endoscopic diverticulotomy using a non-tunnelization techniqueProcedure or surgery
Endoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic treatment with (Z-POEM) | Patients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone. Receives: 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. Receives: Procedure: Endoscopic diverticulotomy using a non-tunnelization technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Clinical success rate after endoscopic treatment.
Clinical success is assessed using the Augsburg scale, with a score <5.
Measured: 3 months
Variation in Augsburg score at different time points
comparing the Augsburg scores at each time point with baseline data for each patient.
Measured: 3 months, 6 months, 12 months, and 24 months
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
Measured: 15 days
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%.
Measured: 3 months
Symptomatic Recurrence Rate Post-Treatment:
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.
Measured: at 3, 6, 12, and 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Oct 2024 (estimated)
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zenker DiverticulumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société Française d'Endoscopie Digestive
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bertrand Brieau, Société Française d'Endoscopie Digestive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594718
- Sponsor's protocol ID
- SFED 157
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Treatment of Zenker's Diverticulum: a Prospective Observational Study Comparing Tunnelization (Z-POEM) Versus Non-Tunnelization Techniques
- ClinicalTrials.gov ID
- NCT06594718
- Acronym / sponsor ID
- SFED 157
- Conditions
- Zenker Diverticulum
- Keywords
- Zenker's diverticulum, Z-POEM, Diverticuloscope, Knife Septotomy, Clutch Cutter
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Société Française d'Endoscopie DigestiveUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endoscopic treatment with (Z-POEM) | – | Procedure: Endoscopic diverticulotomy with Z-POEMPatients undergoing a peroral endoscopic myotomy using a tunneling method to access the target zone. |
| Endoscopic treatment using a non-tunnelization technique | – | Procedure: Endoscopic diverticulotomy using a non-tunnelization techniquePatients undergoing a peroral endoscopic myotomy using a no-tunneling method (Diverticuloscope, Knife Septotomy, and Clutch Cutter) to access the target zone. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient referred for endoscopic treatment of symptomatic Zenker's diverticulum
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic diverticulotomy with Z-POEMEndoscopic diverticulotomy with Z-POEM | Procedure or surgery | Endoscopic treatment with (Z-POEM) |
| Endoscopic diverticulotomy using a non-tunnelization techniqueEndoscopic diverticulotomy with diverticuloscope, Knife Septotomy, or Clutch Cutter | Procedure or surgery | Endoscopic treatment using a non-tunnelization technique |
Primary outcome
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.
5 secondary outcomes
Clinical success rate after endoscopic treatment.
Time frame: 3 months
Variation in Augsburg score at different time points
Time frame: 3 months, 6 months, 12 months, and 24 months
Complication rate associated with the endoscopic procedure
Time frame: 15 days
Radiographic resolution rate of the diverticulum
Time frame: 3 months
Symptomatic Recurrence Rate Post-Treatment:
Time frame: at 3, 6, 12, and 24 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Zenker Diverticulum, run by Société Française d'Endoscopie Digestive.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertrand BRIEAU, MD (+33 650266383, bertrand.brieau@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.