Cricopharyngeal Dysfunction and Esophageal Diverticulum

University of Cincinnati500 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Zenker Diverticulum Progressive Dysphagia Pharyngoesophageal Diverticulum

Interventions

open, transcervical versus rigid endoscopic treatmentPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

Add to the paucity of dysphagia outcomes data after surgical treatment of Zenker's diverticulum.

Demographic data will be summarized for categorical and continuous measures. Continuous data will be compared between groups using student's t-test.

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.

Would standardize the above data and lend increased power due to its multi-institutional nature. The post-operative data will include the following surveys EAT-10, RSI, VHI in order to assess for post-operative resolution of symptoms as well as an esophagram at 12month

Time frame: 5 years

Central Contacts

Becky Reinert, CRC

CONTACT

513-558-1719 gibsonrk@uc.edu

Data from ClinicalTrials.gov

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