NCT03187925

Cricopharyngeal Dysfunction and Esophageal Diverticulum

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Zenker Diverticulum
• Progressive Dysphagia
• Pharyngoesophageal Diverticulum

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-08-15
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2017-06-15
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study