NCT01373125

Brief Summary

The investigators propose a study comparing the morphological and functional aspects of the neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE) to that of native squamous epithelium in normal controls as well as gastroesophageal reflux disease (GERD), non-Barrett's Esophagus (BE) subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 14, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

3.3 years

First QC Date

June 9, 2011

Last Update Submit

September 21, 2015

Conditions

Barrett's EsophagusIntestinal MetaplasiaGastroesophageal Reflux Disease (GERD)

Keywords

Barrett's EsophagusIntestinal metaplasiaGastroesophageal reflux disease (GERD)Neosquamous epitheliumRadiofrequency ablation (RFA)

Outcome Measures

Primary Outcomes (1)

  • To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic Barrett's Esophagus (BE).

    To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic BE. We will compare before and after gastroesophageal reflux disease (GERD) symptom assessment scale (GSAS) symptom scores using paired Student's t tests. As an exploratory analysis, we will further stratify the data by PPI use (once- vs. twice-daily.

    Enrollment

Secondary Outcomes (2)

  • To characterize the physiological and morphological properties of the neosquamous epithelium (NSE)

    Enrollment

  • Correlate the physiologic and morphologic changes in the neosquamous epithelium (NSE) after ablation with the frequency and type of refluxate seen on pH-Impedance.

    Enrollment

Study Arms (4)

Radiofrequency Ablation (RFA)

Participants in this group are greater than or equal to 12 months status post radiofrequency ablation (RFA).

Radiofrequency Ablation Longitudinal (RFAL)

Participants in this group are part of a longitudinal portion of the study and are enrolled prior to their first radiofrequency ablation procedure and followed at 6 and 12 months after completion of RFA.

Gastroesophageal Reflux Disease (GERD)

Participants in this group have been diagnosed with gastroesophageal reflux disease.

Asymptomatic Controls (AC)

Participants in this group are asymptomatic controls and enrolled as part of the comparison group.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Potential subjects will be identified by their gastrointestinal (GI) physician and approached by a study coordinator, nurse, or their GI physician regarding this study on the day of their scheduled procedure at UNC hospitals/GI clinic.

You may qualify if:

  • Eligible subjects will be mentally competent women and men between the ages of 18-80, able to speak and read English and who meet one of the following criteria:
  • Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have undergone radiofrequency ablation (RFA) for BE at the University of North Carolina, Chapel Hill (UNC), or
  • Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing upper endoscopy (EGD) for other indications at UNC, or
  • Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper endoscopy for other indications at UNC.

You may not qualify if:

  • Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy.
  • Current use of warfarin, heparin, and/or low molecular weight heparin (requires discontinuation of medication 5 days prior to and 7 days after EGD).
  • Pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

esophageal biopsies

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Nicholas Shaheen, MD, MPH

    UNC-Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Epidemiology Director, Center for Esophageal Diseases and Swallowing

Study Record Dates

First Submitted

June 9, 2011

First Posted

June 14, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

US(1)