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| Name | Class |
|---|---|
| Centre of Postgraduate Medical Education | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard procedure | Active Comparator | Patients with Zenker's diverticulum treated with flexible endoscopy septotomy. |
|
| Investigational procedure | Experimental | Patients with Zenker's diverticulum treated with peroral endoscopic myotomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peroral endoscopic myotomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy. | 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). | 3 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up | 24 Months | |
| Assessment of clinical symptoms severity measured with the scale EAT-10 | 24 Months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michal Filip Kaminski, MD, PhD | Contact | +48 605438330 | mfkaminski@coi.waw.pl | |
| Aleksandra Budnicka-Borkowicz, MD | Contact | +48 791000890 | olabudnicka@wp.pl |
| Name | Affiliation | Role |
|---|---|---|
| Michal Filip Kaminski, MD, PhD | Professor of Department of Cancer Prevention and Center of Oncology Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Maria Sklodowska-Curie National Research Institute of Oncology | Warsaw | Poland |
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| Label | URL |
|---|---|
| PubMed Identifier | View source |
| PubMed Identifier | View source |
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| Flexible endoscopic septotomy | Procedure | 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. |
|
| Assessment of clinical symptoms severity measured with the scale FOSS |
| 24 Months |
| Percentage of adverse events with graded severity. | 24 Months |
| MedlinePlus | View source |
| ID | Term |
|---|---|
| D016672 | Zenker Diverticulum |
| D004936 | Diverticulum, Esophageal |
| D003680 | Deglutition Disorders |
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004240 | Diverticulum |
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D004066 | Digestive System Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004935 | Esophageal Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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