Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy. (ZIPPY)

Maria Sklodowska-Curie National Research Institute of Oncology

Status: Unknown

Conditions: Gastrointestinal Disease; Dysphagia; Diverticulum, Esophago-Pharyngeal; Zenker Diverticulum; Diverticulum, Esophageal

Treatments: Procedure: Peroral endoscopic myotomy; Procedure: Flexible endoscopic septotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04514042

3299445

Details and patient eligibility

About

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.

Full 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

Enrollment: 165 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 2 patient groups

Standard procedure

Active Comparator group

Description:

Patients with Zenker's diverticulum treated with flexible endoscopy septotomy.

Treatment:

Procedure: Flexible endoscopic septotomy

Investigational procedure

Experimental group

Description:

Patients with Zenker's diverticulum treated with peroral endoscopic myotomy.

Treatment:

Procedure: Peroral endoscopic myotomy