Zenker DiverticulumZIPPYNCT04514042
Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.
A study testing Peroral endoscopic myotomy and Flexible endoscopic septotomy in people with Zenker Diverticulum and Diverticulum, Esophago-Pharyngeal, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
Trial summary
The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal
- What is being tested?
- Peroral endoscopic myotomy and Flexible endoscopic septotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 sitePoland
- Study dates
- Oct 2020to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females who are 18 years of age and older and are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF).
- Patients with symptomatic Zenker's Diverticulum.
- Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations.
- Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations.
Who cannot join
- Lack of written consent for participation in the study.
- Size of Zenker's Diverticulum <1,5 cm or >4 cm on radiological examination.
- Active cancer.
- Esophageal stricture.
- Eosinophilic esophagitis (EoE).
- Pre-cancerous changes in the esophagus.
Show all 12Show fewer
- Previous surgical or endoscopic treatment of Zenker's Diverticulum.
- Presence of chewing deficiencies and/or neurogenic dysphagia.
- Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility disorders.
- Severe systemic diseases which are contraindication to general sedation.
- Severe coagulopathy.
- Pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
Poland1 site
The Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw
About this study
Official title: Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy: International, Multicentre, Randomized, Double-blind Clinical Trial.
The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Patients have a significantly reduced quality of life index and numerous complications.
Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques.
Read more
There is a novel technique, called the peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum.
The ZIPPY trial designed as prospective, international, multicenter, double-blind, randomized study which will be carried out by experienced endoscopists. The aim of this study will be to evaluate the results of Zenker's diverticulum treatment using peroral endoscopic myotomy and to compare its efficacy and safety to flexible endoscopy septotomy. Patients at least 18 years old with symptomatic Zenker's diverticulum diagnosed on the basis of endoscopic and radiological examinations will be enrolled.
Read the detailed description
Participants will be randomized into one of two groups: (I) Z-POEM, (II) flexible endoscopic septotomy. Patients with clinical failure will be offered other method of treatment and will be included to observational cohort. The study has been approved by a local bioethics committee
- Conditions
- Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal, Dysphagia, Gastrointestinal Disease
- Being tested
- Peroral endoscopic myotomy, Flexible endoscopic septotomy
- Keywords
- Cricopharyngeus myotomy, Peroral endoscopic myotomy, Submucosal tunneling endoscopic septum division, Flexible endoscopy septotomy
- Medical subject headings
- Zenker Diverticulum, Diverticulum, Esophageal, Deglutition Disorders, Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peroral endoscopic myotomyProcedure or surgery
Also called Z-POEM
Patients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as peroral endoscopic myotomy. All the procedures will be documented with photographs or videorecordings.
Flexible endoscopic septotomyProcedure or surgery
Patients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as flexible endoscopy septotomy. All the procedures will be documented with photographs or videorecordings.
| Study group | Role | What they receive |
|---|---|---|
| Standard procedure | Active comparator | Patients with Zenker's diverticulum treated with flexible endoscopy septotomy. Receives: Procedure: Flexible endoscopic septotomy |
| Investigational procedure | Experimental | Patients with Zenker's diverticulum treated with peroral endoscopic myotomy. Receives: Procedure: Peroral endoscopic myotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
Measured: 3 Months
Rate of short-term clinical success defined as complete or near complete resolution of postprocedure dysphagia and other related symptoms (regurgitation, halitosis, cough, hoarseness, weight loss, episodes of aspiration pneumonia).
Measured: 3 Months
Secondary outcomes (4)
Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up
Measured: 24 Months
Assessment of clinical symptoms severity measured with the scale EAT-10
Measured: 24 Months
Assessment of clinical symptoms severity measured with the scale FOSS
Measured: 24 Months
Percentage of adverse events with graded severity.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study startOct 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Responsible party
- Sponsor
- Investigators
- Michal Filip Kaminski, MD, PhD, Principal investigator, Professor of Department of Cancer Prevention and Center of Oncology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514042
- Sponsor's protocol ID
- 3299445
- Acronym
- ZIPPY
- Status last verified
- Mar 2020
- First submitted
- 12 Aug 2020
- Last updated
- 14 Aug 2020
- 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 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy: International, Multicentre, Randomized, Double-blind Clinical Trial.
- ClinicalTrials.gov ID
- NCT04514042
- Acronym / sponsor ID
- ZIPPY / 3299445
- Conditions
- Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal, Dysphagia, Gastrointestinal Disease
- Keywords
- Cricopharyngeus myotomy, Peroral endoscopic myotomy, Submucosal tunneling endoscopic septum division, Flexible endoscopy septotomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Maria Sklodowska-Curie National Research Institute of OncologyUniversity, hospital or other
- Collaborators
- Centre of Postgraduate Medical Education
- Study start
- Oct 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Aug 2020 (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.
The Zenker's or pharyngo-esophageal diverticulum is an acquired sac-like outpouching of the mucosa and submucosa layers located dorsally at the pharyngoesophageal junction through Killian's dehiscence. It is the most common type of oesophageal diverticula and typically occurs in middle-aged and elderly patients. Patients have a significantly reduced quality of life index and numerous complications.
Treatment is recommended for symptomatic patients and considering the aetiopathogenesis of the disease demands myotomy of the cricopharyngeal muscle. Myotomy may be pursued through either open surgical or endoscopic techniques.
There is a novel technique, called the peroral endoscopic myotomy (Z-POEM) for treatment of Zenker's diverticulum.
The ZIPPY trial designed as prospective, international, multicenter, double-blind, randomized study which will be carried out by experienced endoscopists. The aim of this study will be to evaluate the results of Zenker's diverticulum treatment using peroral endoscopic myotomy and to compare its efficacy and safety to flexible endoscopy septotomy. Patients at least 18 years old with symptomatic Zenker's diverticulum diagnosed on the basis of endoscopic and radiological examinations will be enrolled.
Detailed description
Participants will be randomized into one of two groups: (I) Z-POEM, (II) flexible endoscopic septotomy. Patients with clinical failure will be offered other method of treatment and will be included to observational cohort. The study has been approved by a local bioethics committee
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard procedure | Active comparator | Procedure: Flexible endoscopic septotomyPatients with Zenker's diverticulum treated with flexible endoscopy septotomy. |
| Investigational procedure | Experimental | Procedure: Peroral endoscopic myotomyPatients with Zenker's diverticulum treated with peroral endoscopic myotomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females who are 18 years of age and older and are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF).
- Patients with symptomatic Zenker's Diverticulum.
- Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations.
- Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations.
Key exclusion criteria (12 listed)
- Lack of written consent for participation in the study.
- Size of Zenker's Diverticulum <1,5 cm or >4 cm on radiological examination.
- Active cancer.
- Esophageal stricture.
- Eosinophilic esophagitis (EoE).
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 |
|---|---|---|
| Peroral endoscopic myotomyAlso: Z-POEMPatients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as peroral endoscopic myotomy. All the procedures will be documented with photographs or videorecordings. | Procedure or surgery | Investigational procedure |
| Flexible endoscopic septotomyPatients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as flexible endoscopy septotomy. All the procedures will be documented with photographs or videorecordings. | Procedure or surgery | Standard procedure |
Primary outcome
Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
Time frame: 3 Months
Rate of short-term clinical success defined as complete or near complete resolution of postprocedure dysphagia and other related symptoms (regurgitation, halitosis, cough, hoarseness, weight loss, episodes of aspiration pneumonia).
Time frame: 3 Months
4 secondary outcomes
Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up
Time frame: 24 Months
Assessment of clinical symptoms severity measured with the scale EAT-10
Time frame: 24 Months
Assessment of clinical symptoms severity measured with the scale FOSS
Time frame: 24 Months
Percentage of adverse events with graded severity.
Time frame: 24 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- PubMed IdentifierLink provided by the sponsor.
- PubMed IdentifierLink provided by the sponsor.
- PubMed IdentifierLink provided by the sponsor.
- MedlinePlusLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
Michal Filip Kaminski, MD, PhD principal investigator
Professor of Department of Cancer Prevention and Center of Oncology Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peroral endoscopic myotomy and Flexible endoscopic septotomy in people with Zenker Diverticulum and Diverticulum, Esophago-Pharyngeal, run by Maria Sklodowska-Curie National Research Institute of Oncology at 1 site in Poland.
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 4 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Filip Kaminski, MD, PhD (+48 605438330, mfkaminski@coi.waw.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy. (time frame: 3 Months). The study lists 2 primary outcomes in all. 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 14 Aug 2020.