A Study to Compare Surveillance vs. Endoscopic Therapy for Barrett's Esophagus with Low-grade Dysplasia

Overview

About this study

The purpose of this study is to compare the effectiveness of two approaches for the management of Barrett's Esophagus (BE) and Low-grade Dysplasia (LGD), endoscopic surveillance and endoscopic eradication therapy (EET), using accepted clinical endpoints of neoplastic progression [high-grade dysplasia (HGD)/mucosal esophageal adenocarcinoma (EAC)/invasive EAC] as determined by a blinded central committee.

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:

  • Any patient with Barrett's Esophagus (BE) and  Low-grade Dysplasia (LGD) who provides informed consent AND meets all the following criteria will be eligible for enrollment.
  • Male or female, age ≥ 18 years.
  • Subject has endoscopic evidence of BE characterized by the presence of salmon-colored mucosa in the tubular esophagus of at least 1 cm in length as well as endoscopic biopsies from the involved areas demonstrating columnar metaplasia with goblet cells. This inclusion criterion will exclude patients with intestinal metaplasia with dysplasia of the gastric cardia.
  • Biopsies within the previous 12 months demonstrating BE and LGD.
  • Confirmation of LGD by expert central pathology panel from biopsies obtained within the previous 12 months (including those obtained from the referring physician).
  • Demonstrated ability to tolerate PPI therapy based on patient self-report; and;
    • Ability to discontinue antiplatelet and anticoagulant therapy based on standard guideline recommendations prior to and after endoscopic procedures.24.
  • We will include non-English speaking patients based on the geographic locations of our sites and the single IRB of record will be responsible for the approval of certified-translated consents.

*Exclusion Criteria:

  • Pregnancy.
  • Prior EET for BE.
  • History of HGD or EAC.
  • History of esophageal resection or esophagectomy.
  • Active erosive esophagitis (Los Angeles Grade B or higher) - patients are eligible upon resolution of erosive esophagitis.
  • Esophageal strictures precluding passage of the endoscope or treatment catheters – patients are eligible upon resolution of esophageal stricture due to endoscopic dilation or resolution with medical therapy.
  • Esophageal varices or known portal hypertension; and;
    • Life expectancy of < 2 years as judged by the site investigator.

*  Patients are eligible for enrollment and randomization if they meet the above eligibility criteria. It should be noted that the presence of a visible lesion (nodularity) at the index endoscopy is not an exclusion criterion.  Those with visible lesions will undergo endoscopic mucosal resection (EMR) to determine pathology. If HGD or EAC pathology is determined, then the subject will exit from the study after a 30-day safety follow up.

Eligibility last updated 7/18/22. Questions regarding updates should be directed to the study team contact.

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

Cadman Leggett, M.D.

Open for enrollment

Contact information:

Erin Gibbons

(507) 255-8692

Gibbons.Erin@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Prasad Iyer, M.D., M.S.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available