A Study to Evaluate Bile Acid Reflux in Patients with Recurrent Barrett’s Esophagus

Overview

About this study

The purpose of this study is to establish the mean concentration of duodenogastric refluxed bile acid in patients with recurrent Barrett’s esophagus (BE) -related intestinal metaplasia, dysplasia, or EAC versus patients who achieved complete remission for at least > 1 year following initial endoscopic intervention, and to establish the composition of duodenogastric refluxed bile acid in patients with BE-related recurrent intestinal metaplasia, dysplasia, or EAC versus patients who achieved complete remission for at least > 1 year following initial endoscopic intervention.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age 18 years or older.
  • Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with endoscopic therapy with negative surveillance endoscopy for at least one year from endoscopic therapy.
  • Dysplastic BE (either low or high grade) or BE-related intramucosal EAC on initial diagnosis successfully treated with initial endoscopic therapy with remission across two subsequent surveillance endoscopies but evidence of recurrence of intestinal metaplasia, dysplasia, or EAC by the third surveillance endoscopy.
  • Tolerance of endoscopy.
  • Ability to give informed consent.

Exclusion Criteria:

  • Age < 18 years old.
  • Pregnancy.
  • Prior gastric surgery.
  • Use of any bile acid sequestrants (cholestyramine, colestipol, and colesevelam) at the time of enrollment.
  • Evidence of biliary obstruction or cholestasis due to any reason, defined as total bilirubin above the upper limit of normal, alkaline phosphatase above the upper limit of normal, and/or clinical evidence of jaundice.
  • Active esophagitis or stricture precluding passage of endoscope and completion of endoscopic procedure.
  • Coagulopathy, defined as INR > 1.5 or platelet level 50,000 precluding completion of endoscopic procedure.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kenneth Wang, M.D.

Closed for enrollment

Contact information:

Kenneth Wang M.D.

(507)255-4631

wang.kenneth@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20472111

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