Seattle Biopsy Protocol Versus Wide-Area Transepithelial Sampling in Patients With Barrett's Esophagus Undergoing Surveillance

Overview

About this study

The purpose of this study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D).  

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 - Surveillance Population:

- Undergoing surveillance endoscopy for a diagnosis of non-dysplastic Barrett's
esophagus (NDBE, based on last endoscopic procedure; patients with prior history of
low-grade dysplasia/indefinite for dysplasia with NDBE at last endoscopy can be
included).

- Barrett's esophagus (BE) length of at least M1.

- English and Spanish speaking.

- Able to comprehend and complete the consent form.

- Age18-89 years.

- Life-expectancy of at least 2 years.

Inclusion Criteria - Screening Population:

- Undergoing endoscopy for screening of BE.

- BE length of at least M1.

- English and Spanish speaking.

- Able to comprehend and complete the consent form.

- Age 18-89 years.

- Expected life-expectancy of at least 2 years.

Inclusion Criteria - Physicians:

-All participating sites will include physicians who are trained in the use of WATS3D and
certified by the site PI. All endoscopists will need to complete a minimum of three cases
to be eligible to participate in the study.

Exclusion Criteria - Surveillance Population:

- BE patients undergoing surveillance or evaluation for endoscopic eradication therapy
(EET) for prior diagnosis of BE related dysplasia or esophageal adenocarcinoma (EAC).

- Active erosive esophagitis with LA Grade B or higher.

- Esophageal varices.

- Prior history of EET.

- Prior history of esophageal or gastric surgery, except for uncomplicated
fundoplication.

- Pregnancy.

Inclusion Criteria - Screening Population:

- BE patients undergoing surveillance or evaluation for EET for prior diagnosis for
BE-related dysplasia or EAC.

- Active erosive esophagitis with LA Grade B or higher.

- Esophageal varices.

- Prior history of esophageal or gastric surgery, except for uncomplicated
fundoplication.

- Pregnancy.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 9/12/22. 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

Don Codipilly, M.D.

Open for enrollment

Contact information:

Erin Gibbons

(507) 255-8692

Gibbons.Erin@mayo.edu

More information

Publications

Publications are currently not available