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

Primary Purpose

Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Peroral endoscopic myotomy
Flexible endoscopic septotomy
Sponsored by
Maria Sklodowska-Curie National Research Institute of Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Zenker Diverticulum focused on measuring Cricopharyngeus myotomy, Peroral endoscopic myotomy, Submucosal tunneling endoscopic septum division, Flexible endoscopy septotomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Maria Sklodowska-Curie National Research Institute of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard procedure

Investigational procedure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
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).

Secondary Outcome Measures

Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up
Assessment of clinical symptoms severity measured with the scale EAT-10
Assessment of clinical symptoms severity measured with the scale FOSS
Percentage of adverse events with graded severity.

Full Information

First Posted
August 12, 2020
Last Updated
August 13, 2020
Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education
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1. Study Identification

Unique Protocol Identification Number
NCT04514042
Brief Title
Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy.
Acronym
ZIPPY
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

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2020 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maria Sklodowska-Curie National Research Institute of Oncology
Collaborators
Centre of Postgraduate Medical Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Zenker Diverticulum, Diverticulum, Esophago-Pharyngeal, Diverticulum, Esophageal, Dysphagia, Gastrointestinal Disease
Keywords
Cricopharyngeus myotomy, Peroral endoscopic myotomy, Submucosal tunneling endoscopic septum division, Flexible endoscopy septotomy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard procedure
Arm Type
Active Comparator
Arm Description
Patients with Zenker's diverticulum treated with flexible endoscopy septotomy.
Arm Title
Investigational procedure
Arm Type
Experimental
Arm Description
Patients with Zenker's diverticulum treated with peroral endoscopic myotomy.
Intervention Type
Procedure
Intervention Name(s)
Peroral endoscopic myotomy
Other Intervention Name(s)
Z-POEM
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Flexible endoscopic septotomy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.
Time Frame
3 Months
Title
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).
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up
Time Frame
24 Months
Title
Assessment of clinical symptoms severity measured with the scale EAT-10
Time Frame
24 Months
Title
Assessment of clinical symptoms severity measured with the scale FOSS
Time Frame
24 Months
Title
Percentage of adverse events with graded severity.
Time Frame
24 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Patients with symptomatic Zenker's Diverticulum. Confirmed diagnosis of Zenker's Diverticulum based on endoscopic and radiological examinations. Size of Zenker's Diverticulum in the range of 1,5 to 4 cm on radiological examinations. Exclusion Criteria: Lack of written consent for participation in the study. Size of Zenker's Diverticulum <1,5 cm or >4 cm on radiological examination. Active cancer. Esophageal stricture. Eosinophilic esophagitis (EoE). Pre-cancerous changes in the esophagus. Previous surgical or endoscopic treatment of Zenker's Diverticulum. Presence of chewing deficiencies and/or neurogenic dysphagia. Presence of other esophageal motility disorders e.g. achalasia and/or spastic motility disorders. Severe systemic diseases which are contraindication to general sedation. Severe coagulopathy. Pregnancy and breastfeeding.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Filip Kaminski, MD, PhD
Phone
+48 605438330
Email
mfkaminski@coi.waw.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Aleksandra Budnicka-Borkowicz, MD
Phone
+48 791000890
Email
olabudnicka@wp.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michal Filip Kaminski, MD, PhD
Organizational Affiliation
Professor of Department of Cancer Prevention and Center of Oncology Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Maria Sklodowska-Curie National Research Institute of Oncology
City
Warsaw
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6441918/
Description
PubMed Identifier
URL
https://pubmed.ncbi.nlm.nih.gov/31082393/
Description
PubMed Identifier
URL
https://pubmed.ncbi.nlm.nih.gov/30453378/
Description
PubMed Identifier
URL
https://medlineplus.gov/endoscopy.html
Description
MedlinePlus

Learn more about this trial

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

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