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NCT Number: NCT03187925

Cricopharyngeal Dysfunction and Esophageal Diverticulum

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.

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Key information

Conditions

Zenker Diverticulum Digestive System Diseases Diverticular Diseases Diverticulum Diverticulum, Esophageal Gastroenteritis Gastrointestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngoesophageal Diverticulum Progressive Dysphagia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Health Otolaryngology-Head and Neck Surgery

Cincinnati, Ohio, 45267, United States

Location status: Recruiting

Location contact

Becky Reinert, CRC

CONTACT

[email protected]

513-558-1719

Rebecca Howell, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

open, transcervical versus rigid endoscopic treatment

Procedure

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.

Other names: observation

Primary outcomes

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

    Time frame: 5 years

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

  2. 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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Becky Reinert, CRC

CONTACT

[email protected]

513-558-1719

Sponsors and collaborators

Lead sponsor

University of Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2017
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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