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Trial record 26 of 226 for:    "Barrett syndrome"

Healing of the Esophageal Mucosa After RFA of Barrett's Esophagus

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ClinicalTrials.gov Identifier: NCT02688114
Recruitment Status : Enrolling by invitation
First Posted : February 23, 2016
Last Update Posted : April 27, 2018
Sponsor:
Information provided by (Responsible Party):
Stuart Spechler, Dallas VA Medical Center

Brief Summary:
Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Procedure: Baseline surveillance endoscopy Procedure: Radiofrequency ablation Procedure: Follow up endoscopy 1 Procedure: Follow up endoscopy 2 Procedure: Follow up endoscopy 3 Not Applicable

Detailed Description:

Radiofrequency ablation (RFA) is a mainstay of treatment for patients who have Barrett's esophagus (BE) with dysplasia. For unclear reasons, Barrett's esophagus recurs after successful RFA treatment in approximately 1/3 of patients. Little is known of how the esophagus heals after RFA treatment, and a better understanding of this healing process might provide insights into how to prevent Barrett's metaplasia from recurring after successful ablation.

The aim of this study is to characterize the healing process of the esophageal mucosa, histologically and at the molecular level, after RFA for non-dysplastic and dysplastic Barrett's esophagus. Patients with Barrett's esophagus will undergo surveillance endoscopy with biopsy. This will be followed by RFA treatment of the BE and follow up endoscopy will be performed 1, 2, and 4 weeks after RFA. Healing at each time point will be assessed endoscopically, and molecular markers related to healing will be studied. Stem cell expression markers, immune cells and markers of epithelial-mesenchymal transition will be compared with baseline expression for each patient. Protocol has been modified to provide a collaborative effort between the Dallas VAMC and Baylor Scott & White Medical Center in Dallas, TX. Veteran participants electing to participate will receive initial screening and endoscopy at the Dallas VAMC and will continue with RFA and follow-up endoscopies at Baylor. An identical protocol has been approved at Baylor Scott & White Medical center. Patients who are screened and enrolled at Baylor will receive all treatments at that location.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Healing of the Esophageal Mucosa After Radiofrequency Ablation of Barrett's Esophagus
Study Start Date : March 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Barrett's Esophagus Treatment
All participants are in the treatment arm. Patients with Barrett's esophagus will undergo baseline surveillance endoscopy, be treated with radiofrequency ablation, and undergo follow up endoscopy 1, follow up endoscopy 2, and follow up endoscopy 3.
Procedure: Baseline surveillance endoscopy
All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.

Procedure: Radiofrequency ablation
All study participants will undergo radiofrequency ablation of Barrett's esophagus

Procedure: Follow up endoscopy 1
All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

Procedure: Follow up endoscopy 2
All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.

Procedure: Follow up endoscopy 3
All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.




Primary Outcome Measures :
  1. Change in the Percent of Mucosa Healed by Neosquamous Epithelium [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    % of the esophageal mucosa healed by Neosquamous epithelium at 1 week, 2 weeks, and 4 weeks after RFA


Secondary Outcome Measures :
  1. Change in expression of genes associated with epithelial-mesenchymal transition, stem cells, and submucosal glands [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Measurement of gene expression in the esophageal mucosa 1 week, 2 weeks, 4 weeks after RFA. Genes related to the process of epithelial-mesenchymal transition, stem cells and submucosal glands will be studied.

  2. Change in inflammatory cell infiltrate [ Time Frame: 1 week, 2 weeks, 4 weeks ]
    Measurement of the changes in inflammatory cell infiltration (neutrophils, eosinophils, lymphocytes) of the esophageal mucosa 1 week, 2 weeks, and 4 weeks after RFA



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Barrett's esophagus

Exclusion Criteria:

  • inability to provide informed consent
  • esophageal varices
  • treatment with warfarin
  • coagulopathy that precludes safe biopsy of the esophagus (including platelet count <100,000/mm3, INR (international normalized ratio) >1.5)
  • allergy to fluorescein sodium
  • comorbidity that precludes safe participation in the study
  • pregnancy or breastfeeding status

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02688114


Locations
United States, Texas
Baylor Scott and White Research Institute
Dallas, Texas, United States, 75204
Dallas VA Medical Center
Dallas, Texas, United States, 75216
Sponsors and Collaborators
Dallas VA Medical Center
Investigators
Principal Investigator: Stuart J Spechler, MD Baylor Scott and White Research Institute

Responsible Party: Stuart Spechler, Chief, Division of Gastroenterology, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT02688114     History of Changes
Other Study ID Numbers: 15-076
First Posted: February 23, 2016    Key Record Dates
Last Update Posted: April 27, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases