Clinical trial NCT04514042: Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.
Official title: Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy: International, Multicentre, Randomized, Double-blind Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Centre of Postgraduate Medical Education
First posted: 2020-08-14
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
timeFrame: 3 Months
measure: 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).
timeFrame: 3 Months
Secondary outcomes:
measure: Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up
timeFrame: 24 Months
measure: Assessment of clinical symptoms severity measured with the scale EAT-10
timeFrame: 24 Months
measure: Assessment of clinical symptoms severity measured with the scale FOSS
timeFrame: 24 Months
measure: Percentage of adverse events with graded severity.
timeFrame: 24 Months
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Maria Sklodowska-Curie National Research Institute of Oncology
Study officials:
affiliation: Professor of Department of Cancer Prevention and Center of Oncology Institute
name: Michal Filip Kaminski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: