Endoscopic Treatment for Zenker's Diverticulum

NCT ID: NCT03948438

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2028-12-30

Brief Summary

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Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.

Detailed Description

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Conditions

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Zenker Diverticulum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Endoscopic septotomy

Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria

* pregnancy and breastfeeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istituto Clinico Humanitas

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanitas Research Hospital

Rozzano, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Alessandro Repici, Prof.

Role: CONTACT

Facility Contacts

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Alesandro Repici, MD

Role: primary

0039-02-82247493

References

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Repici A, Cappello A, Spadaccini M, Nicoletti R, Carrara S, Fugazza A, Galtieri PA, Lamonaca L, Romana C, Badalamenti M, Di Leo M, Pellegatta G, Ferrara EC, Anderloni A, Maselli R. Cap-Assisted Endoscopic Septotomy of Zenker's Diverticulum: Early and Long-Term Outcomes. Am J Gastroenterol. 2021 Sep 1;116(9):1853-1858. doi: 10.14309/ajg.0000000000001356.

Reference Type DERIVED
PMID: 34236338 (View on PubMed)

Other Identifiers

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ICH Zenker

Identifier Type: -

Identifier Source: org_study_id

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