NCT04514042

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 14, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 14, 2020

Status Verified

March 1, 2020

Enrollment Period

1.2 years

First QC Date

August 12, 2020

Last Update Submit

August 13, 2020

Conditions

Zenker DiverticulumDiverticulum, Esophago-PharyngealDiverticulum, EsophagealDysphagiaGastrointestinal Disease

Keywords

Cricopharyngeus myotomyPeroral endoscopic myotomySubmucosal tunneling endoscopic septum divisionFlexible endoscopy septotomy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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

Study Arms (2)

Standard procedure

ACTIVE COMPARATOR

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

Procedure: Flexible endoscopic septotomy

Investigational procedure

EXPERIMENTAL

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

Procedure: Peroral endoscopic myotomy

Interventions

Peroral endoscopic myotomyPROCEDURE

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.

Also known as: Z-POEM
Investigational procedure
Flexible endoscopic septotomyPROCEDURE

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.

Standard procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Maria Sklodowska-Curie National Research Institute of Oncology

Warsaw, Poland

Location

Related Links

MeSH Terms

Conditions

Zenker DiverticulumDiverticulum, EsophagealDeglutition DisordersGastrointestinal Diseases

Condition Hierarchy (Ancestors)

DiverticulumDiverticular DiseasesGastroenteritisDigestive System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Michal Filip Kaminski, MD, PhD

    Professor of Department of Cancer Prevention and Center of Oncology Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michal Filip Kaminski, MD, PhD

CONTACT

+48 605438330mfkaminski@coi.waw.pl

Aleksandra Budnicka-Borkowicz, MD

CONTACT

+48 791000890olabudnicka@wp.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2020

First Posted

August 14, 2020

Study Start

October 1, 2020

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 14, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)