Wide area transepithelial sampling with computer-assisted 3-D tissue analysis, or WATS3D, increased the detection of high-grade dysplasia and esophageal adenocarcinoma more than fourfold compared with the standard Seattle protocol random forceps biopsy, according to the results of a pivotal study.
Healio Gastroenterology reported preliminary data from this study presented at Digestive Disease Week 2016, which have now been published in full in Gastrointestinal Endoscopy.
In the study abstract, investigators described WATS3D (CDx Diagnostics) as “a sampling technique that combines abrasive brushing of the Barrett’s esophagus (BE) mucosa followed by neural network analysis to highlight abnormal-appearing cells.”
Currently, endoscopists rely on taking small random forceps biopsies at 1-cm to 2-cm intervals, which leaves more than 96% of the suspect tissue untested, Prashanth Vennalaganti, MD, of the division of gastroenterology and hepatology at the Kansas City VA Medical Center, said in a press release. “The publication of this study underscores the severe limitations of our current random biopsy protocol as well as the value of taking a few extra minutes to add the WATS3D procedure as a standard of care,” he added.
To evaluate the use of WATS3D as an adjunct to the random biopsy protocol for detecting high-grade dysplasia and esophageal adenocarcinoma in a referral population with BE, Vennalaganti and colleagues randomly assigned 160 patients with BE undergoing surveillance at 16 medical centers to receive either biopsy followed by WATS3D, or vice versa. Most of the patients were white (95%) and male (76%) with a mean age of 63.4 years.
WATS3D detected 29 cases of high-grade dysplasia or esophageal adenocarcinoma (HGD/EAC) while the random biopsy protocol detected only seven cases. Hence, WATS3D provided a 14.4% (95% CI, 7.5-21.2) absolute increase in detection of HGD/EAC. Among the additional 23 cases of HGD/EAC identified by WATS3D, random biopsy identified 11 as non-dysplastic BE and 12 as low-grade dysplasia or indefinite for dysplasia.
The investigators noted that WATS3D added 4.5 minutes to the 7-minute procedure, on average.
“A scientifically rigorous protocol involving some of the most fastidious and meticulous endoscopists and investigators in the country has demonstrated that a simple, easy to use, safe and relatively inexpensive device can significantly enhance the yield for dysplasia and cancer in patients undergoing surveillance endoscopy for Barrett’s esophagus, over and above the current standard (forceps biopsy),” Vivek Kaul, MD, FACG, FASGE, AGAF, chief of the division of gastroenterology and hepatology at University of Rochester Medical Center, told Healio Gastroenterology. “The key to excellent long-term outcomes in BE patients is the reliability and accuracy of tissue sampling and minimizing sampling errors. This device and this study is a huge step in the right direction towards that goal. This type of information has the potential to transform endoscopy practice and that does not happen every day.” – by Adam Leitenberger
Disclosures: Vennalaganti and Kaul report no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.