Comparing treatments for Zenker Diverticulum and related swallowing issues
A Complete Title Used for Approval Letters. Cervical Diverticulum Prospective, Multi-Institutional Study Proposal
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 |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Trial ID | NCT03187925 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients diagnosed with cervical esophageal diverticulum, particularly those with Zenker's diverticulum, regardless of their surgical candidacy.
Not a fit: Patients who undergo flexible endoscopic division of the common wall between the diverticulum and esophagus will not benefit from this study.
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 performed: While there have been studies on similar conditions, this multi-institutional approach focusing on comparative effectiveness is relatively novel.
Eligibility criteria
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 this trial is running
Cincinnati, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.