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

Dysphagia Clinical Trial

— ZIPPY  

Official title:

Comparison of Zenker's Diverticulum Treatment Using Peroral Endoscopic Myotomy and Flexible Endoscopy Septotomy: International, Multicentre, Randomized, Double-blind Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04514042
• Other study ID #: 3299445
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: December 2021

Study information

• Verified date: March 2020
• Source: Maria Sklodowska-Curie Institute - Oncology Center
• Contact: Michal Filip Kaminski, MD, PhD
• Phone: +48 605438330
• Email: mfkaminski[@]coi.waw.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Digestive System Diseases
• Diverticulum
• Diverticulum, Esophageal
• Diverticulum, Esophago-Pharyngeal
• Dysphagia
• Gastrointestinal Disease
• Gastrointestinal Diseases
• Zenker Diverticulum

Intervention

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.
• 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.

Locations

Country	Name	City	State
Poland	The Maria Sklodowska-Curie National Research Institute of Oncology	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Maria Sklodowska-Curie Institute - Oncology Center	Centre of Postgraduate Medical Education

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of procedural technical success defined as completion of all steps of Z-POEM including complete cricopharyngeus myotomy.		3 Months
Primary	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	Rate of long-term clinical success defined as lack of recurrence during 24 months follow-up		24 Months
Secondary	Assessment of clinical symptoms severity measured with the scale EAT-10		24 Months
Secondary	Assessment of clinical symptoms severity measured with the scale FOSS		24 Months
Secondary	Percentage of adverse events with graded severity.		24 Months

External Links

•   MedlinePlus
•   PubMed Identifier
•   PubMed Identifier
•   PubMed Identifier