Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal, Dysphagia, Gastrointestinal Disease
Conditions
Keywords
Cricopharyngeus myotomy, Peroral endoscopic myotomy, Submucosal tunneling endoscopic septum division, Flexible endoscopy septotomy
Brief 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. 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
Interventions
PROCEDUREPeroral endoscopic myotomy
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.
PROCEDUREFlexible endoscopic septotomy
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.
Sponsors
Centre of Postgraduate Medical Education
Maria Sklodowska-Curie National Research Institute of Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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). 2. Patients with symptomatic Zenker's Diverticulum. 3. Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations. 4. Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations.
Exclusion criteria
1. Lack of written consent for participation in the study. 2. Size of Zenker's Diverticulum \<1,5 cm or \>4 cm on radiological examination. 3. Active cancer. 4. Esophageal stricture. 5. Eosinophilic esophagitis (EoE). 6. Pre-cancerous changes in the esophagus. 7. Previous surgical or endoscopic treatment of Zenker's Diverticulum. 8. Presence of chewing deficiencies and/or neurogenic dysphagia. 9. Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility disorders. 10. Severe systemic diseases which are contraindication to general sedation. 11. Severe coagulopathy. 12. Pregnancy and breastfeeding.
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| Assessment of clinical symptoms severity measured with the scale FOSS | 24 Months |
| Percentage of adverse events with graded severity. | 24 Months |
Countries
Poland
Contacts
Primary ContactMichal Filip Kaminski, MD, PhD
Backup ContactAleksandra Budnicka-Borkowicz, MD
Outcome results
None listed