CEDAS - Ongoing Research Studies

Current CEDAS Research

Select a condition below to learn more about current research being conducted by CEDAS.

Barrett's Esophagus

Acid Reflux/Heartburn

Eosinophilic Esophagitis

A Prospective, multi-center, longitudinal cohort study of cryospray ablation of low grade or high grade dysplasia within Barrett's Esophagus (LCS Dysplasia)
PI: Nicholas Shaheen, MD, MPH
Coordinator: Melissa Spacek, CGRN: 216-0247

The purpose of this research study is to learn about the effects (both good and bad) cryospray ablation has on you and your Barrett's Esophagus while you are taking a medication to block the production of stomach acid.

You may be eligible to participate if you have Barrett's esophagus (2 to 6 cm in length) and are between 18 and 85 years of age.

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Risk Perception of Barrett's Esophagus (Pilot Intervention)
PI: Nicholas Shaheen, MD, MPH
Coordinator: Melissa Spacek, CGRN: 216-0247

The purpose of this research study is to evaluate patients perception of cancer risk after teaching them about the real risk through a web-based, interactive, patient-driven interaction. This intervention was developed based on information received on BE patients risk perception.

You may be eligible to participate in this study if you have been diagnosed with Barrett's esophagus over 6 months ago, participated in the study. An Epidemiologic Case-Control Study of Barrett's Esophagus and are between the ages of 18 and 80.

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Angle-Resolved Low Coherence Interferometry As A Means to Detect Dysplasia in Barrett's Esophagus
PI: Nicholas Shaheen, MD, MPH
Coordinator: Stephanie Bright, 216-0712

The purpose of this study is to assess the ability of a technology called Angle-resolved Low Coherence Interferometry (a/LCI) to detect dysplasia in Barrett's esophagus tissue. Participants will have up to 8 additional biopsies during their regular surveillance upper endoscopy for monitoring their Barrett's esophagus in order to compare a/LCI information with conventional tissue slides.

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Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia Trial), A Multi-center, Randomized, Sham-Controlled Trial
PI: Nicholas Shaheen, MD, MPH
Coordinator: Melissa Spacek, CGRN: 216-0247

The purpose of this research study is to learn about the effects (both good and bad) radiofrequency energy (RF) ablation (BARRX therapy) has on you and your Barrett's esophagus while you are taking a medication to block the production of stomach acid.

**This study is ongoing, but is no longer recruiting new patients**

Predictive Biomarkers of Esophageal Adenocarcinoma in Patients with Barrett's Esophagus
PI: Nicholas Shaheen, MD, MPH
Coordinator: Stephanie Bright, 216-0712

The purpose of this study is to learn about the biomarkers that may predict which patients with Barrett's Esophagus develop cancer, and which will not. This is a multi-institution study that will collect previous biopsy samples from local pathology departments for 250 individuals with Barrett's esophagus (approximately 55 at UNC) in order to conduct a variety of scientific tests.

**This study is no longer recruiting participants**

Chronic Cough and Reflux Disease: A Randomized, Double-Blinded, Placebo Controlled Trial of High Dose Proton Pump Inhibitor
PI: Nicholas Shaheen, MD, MPH
Coordinator: Stephanie Bright, 216-0712

The purpose of this research study is to see if different doses of proton pump inhibitors reduce cough symptoms felt to be associated with Gastroesophageal reflux disease (GERD). Proton pump inhibitors are medicines used to treat GERD, which work by lowering the amount of acid in the stomach. The proton pump inhibitor used in this study is called, Esomeprazole (brand name Nexium), and is already marketed for treating GERD. Patients with GERD may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation), belching and coughing. Even very small, unnoticeable amounts of rising stomach acid may cause patients to cough.

You may be eligible to participate in this 13 week study if you are a non-smoking male or female between the ages of 18 and 70 who has had a cough for more than 8 weeks, and are not taking any acid reflux medication.

**This study is no longer recruiting participants**

Effect of Omeprazole Magnesium 20 mg (Prilosec OTC®) on Esophageal Healing Of Microscopic lesions in Non-erosive Frequent Heartburn
PI: Nicholas Shaheen, MD, MPH
Coordinator: Paris Heidt, 216-2626

The purpose of this study is to better understand if omeprazole (Prilosec OTC), when used for short periods of time (14 days) is better capable of healing the invisible or microscopic esophageal damage sometimes caused by Gastroesophageal reflux disease (GERD) than a placebo. This medication is approved by the Food and Drug Administration (FDA), and is available with and without a prescription.

This study lasts approximately 4 weeks, and requires 2 upper endoscopy's and a Bernstein test. You may be eligible to participate if you experience frequent heartburn, and are between the ages of 18 and 75.

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Does Intercellular Space Diameter in Esophageal Epithelium Distinguish between PPI-responsive and PPI-refractory Subjects with Heartburn.
PI: Roy Orlando, MD, PhD
Coordinator: Paris Heidt, 216-2626

The purpose of this study is to better understand the cells which line the esophagus (food pipe), and how these may vary from person to person. For example, some people may have a lot of space in between the cells lining the esophagus, and other people may have much smaller spaces. Dr. Orlando, the principal investigator of this study, believes the reason why some people with heartburn feel better when they take a PPI (a class of drug used to decrease stomach acid) is because of these cellular differences. Esomeprazole (Nexium) is approved in the United States by the Food and Drug Administration (FDA) for the treatment of stomach acid-related diseases, and is available with a prescription from a doctor.

This study lasts approximately 6 weeks, and includes 4 visits to UNC Hospitals, 1 for an upper endoscopy, and three for brief office visits. You may be eligible to participate if you experience frequent heartburn, and are between the ages of 18 and 75.

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Biomarkers of eosinophil activation and inflammation for diagnosis of eosinophilic esophagitis
PI: Evans S. Dellon, MD, MPH
Coordinator: TBD

The purpose of this study is to measure proteins in esophageal biopsy specimens and blood samples that are related to eosinophil function and then to determine if the presence of these proteins is related to the symptoms, endoscopy findings, and biopsy findings in patients with and without difficulty swallowing who might have eosinophilic esophagitis.

This study is not yet recruiting patients (to start in fall, 2008). You may be eligible to participate if you have been referred to have an upper endoscopy either because of trouble swallowing (dysphagia), heartburn, or abdominal pain.

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