Cricopharyngeal Dysfunction and Esophageal Diverticulum

Zenker Diverticulum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03187925
• Other study ID #: 2016-6955
• Status: Recruiting
• Start date: August 15, 2017
• Est. completion date: June 2027

Study information

• Verified date: September 2023
• Source: University of Cincinnati
• Contact: Becky Reinert, CRC
• Phone: 513-558-1719
• Email: gibsonrk[@]uc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diverticulum
• Pharyngoesophageal Diverticulum
• Progressive Dysphagia
• Zenker Diverticulum

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
United States	UC Health Otolaryngology-Head and Neck Surgery	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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