Cricopharyngeal Dysfunction and Esophageal Diverticulum
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorUniversity of Cincinnati
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients who undergo division of the common wall between the diverticulum and esophagus using flexible endoscopy will not be included in the study.
Trial population
No intended gender or racial/ethnic distribution. Intended age range is 18-100 years of age. The vulnerable population (patients) will be protected from potential coercion or undue influence as this is an observational study with elective participation in follow-up patient surveys in which patient data will otherwise be deidentified upon inspection
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
open, transcervical versus rigid endoscopic treatment
Procedure/SurgeryThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 years2
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 yearsSponsors and contacts
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Source ClinicalTrials.gov