Cricopharyngeal Dysfunction and Esophageal Diverticulum

NCT ID: NCT03187925

Last Updated: 2023-09-13

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

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-15

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Zenker Diverticulum Progressive Dysphagia Pharyngoesophageal Diverticulum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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open, transcervical versus rigid endoscopic treatment

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.

Intervention Type PROCEDURE

Other Intervention Names

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observation

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Rebecca Howell

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecca J Howell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

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UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Becky Reinert, CRC

Role: CONTACT

513-558-1719

Facility Contacts

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Becky Reinert, CRC

Role: primary

513-558-1719

References

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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.

Reference Type BACKGROUND
PMID: 12150380 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19140539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22279951 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22350426 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24496741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25194579 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25026961 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28052332 (View on PubMed)

Other Identifiers

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2016-6955

Identifier Type: -

Identifier Source: org_study_id

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