Cricopharyngeal Dysfunction and Esophageal Diverticulum

NCT03187925 | Recruiting FDA Device

• 1 other identifier: 2016-6955
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Zenker Diverticulum; Progressive Dysphagia; Pharyngoesophageal Diverticulum

Outcome Measures

Primary Outcomes (2)

• 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.

  5 years

• 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

  5 years

Interventions

open, transcervical versus rigid endoscopic treatment PROCEDURE

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.

Also known as: observation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Cincinnati: lead

Study Sites (1)

UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, 45267, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 12150380 BACKGROUND

• 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.

  PMID: 19140539 BACKGROUND

• 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.

  PMID: 22279951 BACKGROUND

• 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.

  PMID: 22350426 BACKGROUND

• 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.

  PMID: 24496741 BACKGROUND

• 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.

  PMID: 25194579 BACKGROUND

• 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.

  PMID: 25026961 BACKGROUND

• 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.

  PMID: 28052332 BACKGROUND

MeSH Terms

Conditions

Zenker Diverticulum

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Rebecca J Howell, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Becky Reinert, CRC

CONTACT

513-558-1719; gibsonrk@uc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: June 2, 2017
• First Posted: June 15, 2017
• Study Start: August 15, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

US (1)