Cricopharyngeal Dysfunction and Esophageal Diverticulum

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Zenker Diverticulum, Progressive Dysphagia, Pharyngoesophageal Diverticulum

Intervention / Treatment
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* Procedure: open, transcervical versus rigid endoscopic treatment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 5 years |