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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Dysphagia; Gastrointestinal Disease; Zenker Diverticulum; Diverticulum, Esophageal; Diverticulum, Esophago-Pharyngeal
• Intervention / Treatment: Procedure: Flexible endoscopic septotomy; Procedure: Peroral endoscopic myotomy

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 Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland
    • The Maria Sklodowska-Curie National Research Institute of Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard procedure; Patients with Zenker's diverticulum treated with flexible endoscopy septotomy.	Procedure: Flexible 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.
Experimental: Investigational procedure; Patients with Zenker's diverticulum treated with peroral endoscopic myotomy.	Procedure: Peroral 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.; Other Names: Z-POEM

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Maria Sklodowska-Curie National Research Institute of Oncology
• Collaborators: Centre of Postgraduate Medical Education
• Investigators: Principal Investigator: Michal Filip Kaminski, MD, PhD, Professor of Department of Cancer Prevention and Center of Oncology Institute

Publications and helpful links

Helpful Links

• PubMed Identifier
• PubMed Identifier
• PubMed Identifier
• MedlinePlus

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 12, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Peroral endoscopic myotomy; Cricopharyngeus myotomy; Submucosal tunneling endoscopic septum division; Flexible endoscopy septotomy
• Additional Relevant MeSH Terms: Gastroenteritis; Pathological Conditions, Anatomical; Gastrointestinal Diseases; Digestive System Diseases; Diverticulum; Diverticular Diseases; Zenker Diverticulum; Diverticulum, Esophageal
• Other Study ID Numbers: 3299445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No