Recruiting

Observational Study

Sponsor:

University of Cincinnati

Code:

NCT03187925

Conditions

Zenker Diverticulum

Progressive Dysphagia

Pharyngoesophageal Diverticulum

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

open, transcervical versus rigid endoscopic treatment

Study Details

Brief 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.

Conditions

Zenker Diverticulum

Progressive Dysphagia

Pharyngoesophageal Diverticulum

Study ID

NCT03187925

Start date

Aug 15, 2017

Status verified date

Sep, 2023

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Add to the paucity of dysphagia outcomes data after surgical treatment of Zenker's diverticulum. [ Time Frame: 5 years ]
  • 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. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Becky Reinert, CRC

513-558-1719gibsonrk@uc.edu

Locations

UC Health Otolaryngology-Head and Neck Surgery

Recruiting

Cincinnati, Ohio, United States, 45267

Contacts

Becky Reinert, CRC

513-558-1719gibsonrk@uc.edu

Principal Investigator:

Rebecca Howell, MD

More Information

Sponsor

University of Cincinnati

Last update posted

Sep 13, 2023

Last verified

Sep, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2023-09-13.