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Endoscopic Tissue Sampling Methods in Patients with Barrett’s Esophagus Undergoing Surveillance, SWAT-BE Study
Trial Status: active
This clinical trial compares the endoscopic surveillance approach of the standard Seattle biopsy protocol versus WATS3D sampling plus target biopsies in patients with known or suspected Barrett's esophagus. Barrett’s esophagus is a common condition with increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. Barrett’s esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. Endoscopic surveillance is a type of procedure where a tube with a light and a camera on the end of it down goes down the throat and removes a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. The Seattle biopsy protocol samples are obtained from the Barrett's esophagus in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas. The wide area transepithelial sampling utilizes brushings from the Barrett's esophagus. Comparing the standard Seattle biopsy protocol to sampling using WATS3D may help doctors learn about the best approach to sample patients with known or suspected Barrett's esophagus.
Inclusion Criteria
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: Undergoing surveillance endoscopy for a diagnosis of non-dysplastic BE (NDBE, based on last endoscopic procedure; patients with prior history of LGD/indefinite for dysplasia with NDBE at last endoscopy can be included)
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: BE length of at least M1
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: English and Spanish speaking
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: Able to comprehend and complete the consent form
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: Age18-89 years
PATIENT INCLUSION FOR THE SURVEILLANCE POPULATION: Life-expectancy of at least 2 years
PHYSICIANS INCLUSION FOR THE SURVEILLANCE POPULATION: All participating sites will include physicians who are trained in the use of WATS3D by the site principal investigator (PI) and will need to complete a minimum of three cases to be eligible to participate in this study
PATIENT INCLUSION FOR THE SCREENING POPULATION: Undergoing endoscopy for screening of BE
PATIENT INCLUSION FOR THE SCREENING POPULATION: BE length of at least M1
PATIENT INCLUSION FOR THE SCREENING POPULATION: English and Spanish speaking
PATIENT INCLUSION FOR THE SCREENING POPULATION: Able to comprehend and complete the consent form
PATIENT INCLUSION FOR THE SCREENING POPULATION: Age 18-89 years
PATIENT INCLUSION FOR THE SCREENING POPULATION: Expected life-expectancy of at least 2 years
PHYSICIANS INCLUSION FOR THE SCREENING POPULATION: 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
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: BE patients undergoing surveillance or evaluation for EET for prior diagnosis of BE related dysplasia or EAC
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: Active erosive esophagitis with Los Angeles (LA) Grade B or higher
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: Esophageal varices
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: Prior history of EET
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
PATIENT EXCLUSION FOR THE SURVEILLANCE POPULATION: Pregnancy
PATIENT EXCLUSION FOR THE SCREENING POPULATION: BE patients undergoing surveillance or evaluation for EET for prior diagnosis for BE-related dysplasia or EAC
PATIENT EXCLUSION FOR THE SCREENING POPULATION: Active erosive esophagitis with LA Grade B or higher
PATIENT EXCLUSION FOR THE SCREENING POPULATION: Esophageal varices
PATIENT EXCLUSION FOR THE SCREENING POPULATION: Prior history of esophageal or gastric surgery, except for uncomplicated fundoplication
PATIENT EXCLUSION FOR THE SCREENING POPULATION: Pregnancy
Additional locations may be listed on ClinicalTrials.gov for NCT05530343.
I. To compare the diagnostic yield of low-grade dysplasia (LGD)/high-grade dysplasia (HGD)/esophageal adenocarcinoma (EAC) in Barrett's esophagus (BE) patients undergoing surveillance between the standard Seattle biopsy protocol (4-quadrant biopsy every 2 cm with target biopsies from any visible lesions) with sampling using wide-area transepithelial sampling with 3-dimensional computer-assisted analysis (WATS3D) plus target biopsies from any visible lesions. (Surveillance population)
II. To compare the diagnostic yield of intestinal metaplasia between the standard Seattle biopsy protocol (4-quadrant biopsies every 2 cm plus target biopsies from any visible lesions) with sampling using WATS3D plus target biopsies from any visible lesion. (Screening population)
SECONDARY OBJECTIVES:
I. To compare the detection of intestinal metaplasia between these two strategies. (Surveillance population)
II. To compare the diagnostic yield of LGD/HGD/EAC between the standard Seattle biopsy protocol plus WATS3D sampling technique compared with the standard Seattle biopsy protocol alone. (Surveillance population)
III. To compare the time required to complete both procedures. (Surveillance population)
IV. To conduct a cost-effectiveness analysis between the two strategies. (Surveillance population)
V. To compare the number of patients referred for endoscopic eradication therapy (EET). (Surveillance population)
VI. To assess interobserver agreement among pathologists for WATS3D specimens. (Surveillance population)
VII. To determine the predictors of dysplasia in patients with non-dysplastic BE patients undergoing surveillance (overall and based on sampling technique). (Surveillance population)
VIII. To establish a tissue repository of WATS3D specimens with the goal of identifying biomarkers associated with the risk of progression. (Surveillance population)
IX. To compare the detection of dysplasia (LGD and HGD) and EAC between the standard Seattle biopsy protocol (4-quadrant biopsies every 2 cm plus target biopsies from any visible lesions) with sampling using WATS3D plus target biopsies from any visible lesion. (Screening population)
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients undergo esophagogastroduodenoscopy (EGD) with the standard Seattle biopsy protocol first, followed by EGD with the WATS3D plus target biopsies on study.
GROUP II: Patients undergo EGD with the WATS3D plus target biopsies first followed by EGD with the standard Seattle biopsy protocol on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationUCHealth University of Colorado Hospital
