Comparing treatments for Zenker Diverticulum and related swallowing issues
Official title: A Complete Title Used for Approval Letters. Cervical Diverticulum Prospective, Multi-Institutional Study Proposal
Run by University of Cincinnati · NCT03187925 · Data updated 2026-11-12
This study is testing which treatment method works better for people with Zenker's diverticulum and swallowing problems by comparing surgery through the neck to a less invasive endoscopic approach.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 100 Years |
| Sex | All |
| Enrollment | 500 (estimated) |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | August 15, 2017 |
| Main results expected | June 2027 |
| Study ends | June 2027 |
| Registry record updated | September 13, 2023 |
| Trial ID | NCT03187925 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients diagnosed with cervical esophageal diverticulum, particularly those with Zenker's diverticulum, regardless of their surgical candidacy.
✕Probably not a fit
Patients who undergo flexible endoscopic division of the common wall between the diverticulum and esophagus will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to compare the effectiveness of open transcervical and endoscopic approaches for treating cervical esophageal diverticulum, particularly Zenker's diverticulum. Patients will undergo standardized diagnostic assessments and treatment approaches, with pre-operative and post-operative evaluations of symptoms. The study will also analyze how factors like age, diverticulum size, and co-morbidities affect treatment outcomes, providing valuable insights into patient stratification and management.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients suffering from swallowing difficulties due to diverticula.
How similar studies have gone: While there have been studies on similar conditions, this multi-institutional approach focusing on comparative effectiveness is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
UC Health Otolaryngology-Head and Neck Surgery
Cincinnati, Ohio, United States Recruiting
Study contacts
- Principal investigator: Rebecca J Howell, MD — University of Cincinnati
- Study coordinator: Becky Reinert, CRC
- Email: gibsonrk@uc.edu
- Phone: 513-558-1719
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Evaluating the use of endoscopic myotomy for gastrointestinal motility disorders
This study is testing how well a procedure called endoscopic myotomy works for people with different gastrointestinal motility disorders like achalasia and gastroparesis over several years.
-
Registry for advanced endoscopic procedures
This study is collecting information from patients who are having advanced endoscopy procedures for gastrointestinal diseases to see how well these treatments work and improve patient care.
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Endoscopic treatment for Zenker's diverticulum
This study is testing new, less invasive methods to treat Zenker's diverticulum and see if they can help reduce symptoms for people with this condition.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.