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Endoscopic Treatment for Zenker's Diverticulum

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03948438
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : August 28, 2020
Sponsor:
Information provided by (Responsible Party):
Istituto Clinico Humanitas

Brief Summary:
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.

Condition or disease Intervention/treatment
Zenker Diverticulum Procedure: Endoscopic septotomy

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Outcome of Endoscopic Treatment for Zenker's Diverticulum
Actual Study Start Date : January 1, 2009
Estimated Primary Completion Date : December 30, 2028
Estimated Study Completion Date : December 30, 2028

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: 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)


Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: 24 hours after the procedure ]
    Any complications as bleeding, perforation, others


Secondary Outcome Measures :
  1. symptoms after the procedure [ Time Frame: up to 5 years ]
    The frequency of symptoms such as dysphagia, regurgitation, weight loss



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients affected by ZD and treated by endoscopic procedures.
Criteria

Inclusion Criteria:

  • patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

  • pregnancy and breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03948438


Contacts
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Contact: Alessandro Repici, Prof. alessandro.repici@hunimed.eu

Locations
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Italy
Humanitas Research Hospital Recruiting
Rozzano, Italy, 20089
Contact: Alesandro Repici, MD    0039-02-82247493    alessandro.repici@hunimed.eu   
Sub-Investigator: Milena Di Leo, MD         
Sub-Investigator: Roberta Maselli, PhD         
Sub-Investigator: Piera A Galtieri, MD         
Sub-Investigator: Elena Finati         
Sponsors and Collaborators
Istituto Clinico Humanitas
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Responsible Party: Istituto Clinico Humanitas
ClinicalTrials.gov Identifier: NCT03948438    
Other Study ID Numbers: ICH Zenker
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: August 28, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diverticulum
Diverticular Diseases
Zenker Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Diverticulum, Esophageal