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NCT Number: NCT03948438

Endoscopic Treatment for Zenker's Diverticulum

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.

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Key information

Conditions

Zenker Diverticulum Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Esophageal Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Humanitas Research Hospital

Rozzano, 20089, Italy

Location status: Recruiting

Location contact

Alesandro Repici, MD

CONTACT

[email protected]

0039-02-82247493

Elena Finati

SUB_INVESTIGATOR

Milena Di Leo, MD

SUB_INVESTIGATOR

Piera A Galtieri, MD

SUB_INVESTIGATOR

Roberta Maselli, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with symptomatic ZD treated by endoscopic procedures

Exclusion criteria

  • pregnancy and breastfeeding

Treatment and study plan

Endoscopic septotomy

Procedure

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)

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: 24 hours after the procedure

    Any complications as bleeding, perforation, others

Secondary outcomes

  1. symptoms after the procedure

    Time frame: up to 5 years

    The frequency of symptoms such as dysphagia, regurgitation, weight loss

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandro Repici, Prof.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Registry information

Official study title

Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum

Important dates

Study start
2009
Primary completion
2028
Study completion
2028
First posted
May 14, 2019
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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