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Zenker DiverticulumNCT03187925

Cricopharyngeal Dysfunction and Esophageal Diverticulum

An observational study of Zenker Diverticulum and Progressive Dysphagia, run by University of Cincinnati at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
open, transcervical versus rigid endoscopic treatment
Type of treatment
Surgery or procedure
How many people
500 participants
Where
1 siteUnited States
Study dates
15 Aug 2017to Jun 2027
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: No intended gender or racial/ethnic distribution. Intended age range is 18-100 years of age. The vulnerable population (patients) will be protected from potential coercion or undue influence as this is an observational study with elective participation in follow-up patient surveys in which patient data will otherwise be deidentified upon inspection

Who may be able to join

  • Patients with a diagnosis of cervical esophageal diverticulum, with Zenker's as most common, or CP bar (with diagnosis of early Zenker) as indicated on an esophagram who the participating institutions enroll regardless of surgical management and future treatments. Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

Who cannot join

  • Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Becky Reinert, CRC contact

513-558-1719

gibsonrk@uc.edu

United States1 site, 1 recruiting

  • UC Health Otolaryngology-Head and Neck Surgery

    Cincinnati, Ohio, 45267

    Becky Reinert, CRC, 513-558-1719, gibsonrk@uc.edu

    Rebecca Howell, MD

    Recruiting

Other trials in United States

About this study

Official title: A Complete Title Used for Approval Letters. Cervical Diverticulum Prospective, Multi-Institutional Study Proposal

Patients undergoing open transcervical or endoscopic approach in which a laser or stapler is used to divide the common wall between the diverticulum and esophagus, or who are not surgical candidates but agree to follow-up.

Read the detailed description

A prospective, multi-institutional study comparing the effectiveness of the above procedures will provide a large cohort using standardized diagnostic studies, diverticulum size measurements, treatment approaches, pre-operative and post-operative assessment of symptoms in order to both compare the effectiveness of the procedures and to stratify the patients in order to determine whether demographics such as age, pre-operative size, and/or peri-operative co-morbidities influence outcomes.

Being tested
open, transcervical versus rigid endoscopic treatment
Medical subject headings
Zenker Diverticulum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • open, transcervical versus rigid endoscopic treatmentProcedure or surgery

    Also called observation

    The goal of the project is to perform the first prospective, multi-institutional long-term (5 year) study comparing the outcomes of open, transcervical versus rigid endoscopic treatment of cervical esophageal diverticulum and cricopharyngeal dysfunction in resolving associated symptoms, complications, and recurrence rates of dysphagia surgery. This study will also include cricopharyngeal bar as it pertains to an early Zenker's diverticulum.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Add to the paucity of dysphagia outcomes data after surgical treatment of Zenker's diverticulum.

    Demographic data will be summarized for categorical and continuous measures. Continuous data will be compared between groups using student's t-test.

    Measured: 5 years

  2. Include dysphagia outcomes comparing both endoscopic and open repair of Zenker's diverticulum to develop preliminary evidence-based indications and long-term outcomes, exploring various relevant subset analyses.

    Would standardize the above data and lend increased power due to its multi-institutional nature. The post-operative data will include the following surveys EAT-10, RSI, VHI in order to assess for post-operative resolution of symptoms as well as an esophagram at 12month

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2017
  2. Study start15 Aug 2017
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03187925
Sponsor's protocol ID
2016-6955
Status last verified
Sep 2023
First submitted
2 Jun 2017
Last updated
13 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Belafsky PC, Postma GN, Koufman JA. Validity and reliability of the reflux symptom index (RSI). J Voice. 2002 Jun;16(2):274-7. doi: 10.1016/s0892-1997(02)00097-8.

    PubMed 12150380

  • Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210.

    PubMed 19140539

  • Bock JM, Van Daele DJ, Gupta N, Blumin JH. Management of Zenker's diverticulum in the endoscopic age: current practice patterns. Ann Otol Rhinol Laryngol. 2011 Dec;120(12):796-806. doi: 10.1177/000348941112001205.

    PubMed 22279951

  • Leong SC, Wilkie MD, Webb CJ. Endoscopic stapling of Zenker's diverticulum: establishing national baselines for auditing clinical outcomes in the United Kingdom. Eur Arch Otorhinolaryngol. 2012 Aug;269(8):1877-84. doi: 10.1007/s00405-012-1945-3. Epub 2012 Feb 17.

    PubMed 22350426

  • Parker NP, Misono S. Carbon dioxide laser versus stapler-assisted endoscopic Zenker's diverticulotomy: a systematic review and meta-analysis. Otolaryngol Head Neck Surg. 2014 May;150(5):750-3. doi: 10.1177/0194599814521554. Epub 2014 Feb 4.

    PubMed 24496741

  • Verdonck J, Morton RP. Systematic review on treatment of Zenker's diverticulum. Eur Arch Otorhinolaryngol. 2015 Nov;272(11):3095-107. doi: 10.1007/s00405-014-3267-0. Epub 2014 Sep 7.

    PubMed 25194579

  • Wilken R, Whited C, Scher RL. Endoscopic staple diverticulostomy for Zenker's diverticulum: review of experience in 337 cases. Ann Otol Rhinol Laryngol. 2015 Jan;124(1):21-9. doi: 10.1177/0003489414542421. Epub 2014 Jul 15.

    PubMed 25026961

  • Venkatesan NN, Evangelista LM, Kuhn MA, Belafsky PC. Normal fluoroscopic appearance status post-successful endoscopic Zenker diverticulotomy. Laryngoscope. 2017 Aug;127(8):1762-1766. doi: 10.1002/lary.26446. Epub 2017 Jan 4.

    PubMed 28052332

Questions about this trial

What is this clinical trial studying?

An observational study of Zenker Diverticulum and Progressive Dysphagia, run by University of Cincinnati at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Becky Reinert, CRC (513-558-1719, gibsonrk@uc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Add to the paucity of dysphagia outcomes data after surgical treatment of Zenker's diverticulum. (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03187925, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.

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