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Prevalence of Dysplasia of the Gastric Cardia


N/A
18 Years
80 Years
Open (Enrolling)
Both
Barrett's Esophagus, Intestinal Metaplasia, Intramucosal Adenocarcinoma

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Trial Information

Prevalence of Dysplasia of the Gastric Cardia


This study will consist of a cross-sectional arm, as well as a prospective longitudinal arm,
and will include patients who are undergoing ablative therapy at UNC. The cross-sectional
arm will consist of patients who have undergone ablative therapy for Barrett's Esophagus
(BE) and have had at least one clear pathology report with no evidence of Barrett's
Esophagus (BE) since their first ablation. Concurrently enrolled will be a prospective
longitudinal arm which will consist of patients prior to their first ablation procedure. The
prospective cohort will be followed for 12 months or longer if Barrett's Esophagus (BE) is
not yet clear 6 months after the initial treatment.

Sampling of the gastric cardia for clinical pathology has become common in patients who are
receiving or have received ablation therapy based on evidence from previous research
suggesting concern for dysplasia in the gastric cardia. In each group, research biopsies
will be taken at the top of the gastric folds (TGF) as well as the gastric cardia (TGF+1cm)
and distal esophagus (TGF-1).

Clinical biopsies will consist of standard esophageal biopsies from the distal esophagus as
well as biopsies from TGF, TGF+1cm and TGF+2 cm. Clinical biopsy specimens will be fixed and
reviewed by a pathologist to determine the presence of any metaplastic, dysplastic, or
neoplastic changes, as per our usual clinical practice. Research specimens will undergo
immunohistochemical (IHC) staining for a number of biomarkers that have been found to be
positive in patients with dysplastic BE (p16, p53, Ki67, cyclin D1, and cyclin A). 1-4
Cross-sectional participants will receive one-time study biopsies. Prospective longitudinal
participants will receive biopsies prior to ablation therapy and 6 and 12 months after the
initial treatment. If Barrett's Esophagus (BE) is not yet clear at 6 months, biopsies will
be taken at the first endoscopy after Barrett's Esophagus (BE) clearance and again at the
next clinically scheduled follow-up visit.


Inclusion Criteria:



- English speaking males or females aged 18 to 80.

- Meet one of the following:

1. Individuals who have undergone ablation therapy for dysplastic Barrett's
Esophagus (BE) or intramucosal adenocarcinoma and have had at least one clear
pathology report with no BE since their first ablation (cross-sectional) OR

2. Individuals with dysplastic Barrett's Esophagus (BE) or intramucosal
adenocarcinoma who will undergo ablation therapy at UNC for the first time
(prospective longitudinal)

- Able to read, comprehend, and complete the informed consent form.

Exclusion Criteria:

- Bleeding disorder or other contraindication of endoscopic biopsy.

- Current use of blood thinners such as coumadin, warfarin, heparin and/or low
molecular weight heparin (requires discontinuation of medication 5 days prior to and
6 days after Esophagogastroduodenoscopy (EGD)).

- History of partial or complete esophagectomy.

- Current diagnosis of invasive esophageal cancer.

- Pregnant women.

Type of Study:

Observational

Study Design:

Observational Model: Cohort

Outcome Measure:

Presence of dysplasia before and after ablation

Outcome Description:

Simple proportions will be generated to describe the prevalence of cardiac dysplasia prior to endoscopic ablation. To compare the proportion of subjects demonstrating cardiac dysplasia who have had complete eradication of Barrett's Esophagus (BE) to the proportion of subjects demonstrating cardiac dysplasia who have not had complete eradication of Barrett's Esophagus (BE), due to the dichotomous nature of the variable, we will initially create 2x2 contingency tables and perform bivariate analysis using χ2, which will serve as our primary statistical analysis. Effects will be summarized as risk ratios. To analyze the operating characteristics of various biomarkers to predict cardiac dysplasia, sensitivity, specificity, positive predictive value and negative predictive value of each biomarker to predict the presence of dysplasia at 6 and 12 months will be calculated.

Outcome Time Frame:

Enrollment and 6 and 12 months post treatment

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

12-0336

NCT ID:

NCT01787864

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Barrett's Esophagus
  • Intestinal Metaplasia
  • Intramucosal Adenocarcinoma
  • Barrett's Esophagus
  • Intestinal metaplasia
  • Intramucosal Adenocarcinoma
  • Gastric Cardia
  • High Cardia Dysplasia
  • Radiofrequency ablation (RFA)
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Barrett Esophagus
  • Metaplasia

Name

Location

University of North Carolina at Chapel HillChapel Hill, North Carolina  27599