RecruitingNCT03187925

Cricopharyngeal Dysfunction and Esophageal Diverticulum

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


Sponsor

University of Cincinnati

Enrollment

500 participants

Start Date

Aug 15, 2017

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria1

  • 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 Criteria1

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

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Interventions

PROCEDUREopen, 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(1)

UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, United States

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NCT03187925


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