Cricopharyngeal Dysfunction and Esophageal Diverticulum

University of Cincinnati

Status: Enrolling

Conditions: Progressive Dysphagia; Pharyngoesophageal Diverticulum; Zenker Diverticulum

Treatments: Procedure: open, transcervical versus rigid endoscopic treatment

Study type: Observational

Funder types: Other

Identifiers

NCT03187925

2016-6955

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.