The purpose of this research 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).
Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer.
Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove 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.
Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD).
Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE.
While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other.
Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized.
Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.
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
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
Crossover
Seattle protocol
Diagnostic testParticipants undergo 4-quadrant biopsies with standard biopsy forceps taken at 2 cm intervals. For participants undergoing a confirmatory endoscopy for cases in which discordant results are noted (WATS3D positive for dysplasia/cancer and Seattle biopsy negative for dysplasia/cancer), repeat biopsies will be taken at 1 cm intervals along with target biopsies from any visible lesions.
WATS3D brushings
Diagnostic testParticipants undergo 2 WATS3D biopsies of every 5 cm segment of Barrett's esophagus, starting from the gastroesophageal junction and moving proximally through the entire segment of Barrett's.
Diagnostic yield of dysplasia (Surveillance population only)
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC). All positive results for dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
Diagnostic yield of intestinal metaplasia (Screening population only)
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia. All positive results for intestinal metaplasia/dysplasia or esophageal adenocarcinoma (EAC) with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
Detection of intestinal metaplasia (Surveillance population only)
Proportion of positive results between the Seattle protocol and WATS3D technique. Positive results include intestinal metaplasia.
Diagnostic yield between the Seattle protocol and WATS3D Vs. the Seattle protocol alone (Surveillance population only)
Proportion of positive results of low-grade dysplasia (LGD), high-grade dysplasia (HGD), and esophageal adenocarcinoma (EAC) between the Seattle protocol and WATS3D technique Vs. the WATS3D technique alone. All positive results for intestinal metaplasia/dysplasia or EAC with WATS3D sampling not detected on Seattle biopsy protocol at index endoscopy will require confirmation by repeat sampling using the Seattle biopsy protocol.
Time of procedure as measured by total sampling time (Surveillance population only)
Total sampling time for the Seattle protocol is measured by the time the first forceps biopsy was placed into the channel to the time the final forceps biopsy was removed from the channel. Total sampling time for the WATS3D technique is measured by the time the first WATS3D brush was placed into the channel to the time the final WATS3D brush was removed from the channel.
Quality adjusted life years (Surveillance population only)
The investigators will conduct a cost-effectiveness analysis between the two sampling techniques using data collected from the randomized control trial (cost for procedures and follow-up, detection of dysplasia or cancer, need for endoscopic eradication therapies, biopsy and pathology costs, complications, among others). The primary endpoint for the cost-effectiveness analysis will be the incremental cost-effectiveness ratio with a predefined willingness to pay off $100k per quality adjusted life years.
Click on the lead sponsor to view all of their trials.
