TY - JOUR
T1 - Wide-area transepithelial sampling with computer-assisted analysis to detect high grade dysplasia and cancer in Barrett's esophagus
T2 - a multicenter randomized study
AU - van Munster, Sanne N
AU - Leclercq, Philippe
AU - Haidry, Rehan
AU - Messmann, Helmut
AU - Probst, Andreas
AU - Ragunath, Krish
AU - Bhandari, Pradeep
AU - Repici, Alessandro
AU - Munoz-Navas, Miguel
AU - Seewald, Stefan
AU - Lemmers, Arnaud
AU - Fernández-Esparrach, Glòria
AU - Pech, Oliver
AU - Schoon, Erik J
AU - Kariv, Revital
AU - Neuhaus, Horst
AU - Weusten, Bas L A M
AU - Siersema, Peter D
AU - Correale, Loredana
AU - Meijer, Sybren L
AU - de Hertogh, Gert
AU - Bergman, Jacques J G H M
AU - Hassan, Cesare
AU - Bisschops, Raf
N1 - Funding Information:
The study was financially supported by CDx diagnostics, Inc. CDx diagnostics supported the study personnel cost and provided study brushes. The sponsor had no role in the design and conduct of the study; collection; management; analysis; and interpretation of the data. The sponsor was provided with a draft prior to submission and did submit feedback to the authors. RB has received consultancy fees from CDx Diagnostics. GH’s employer University of Leuven receives payments for involvement as central pathology reader in the study. RK is supported by grant from Pfizer. PDS is supported by a grant from Pentax, MicroTech, The Enose company and Motus GI. KR received consultancy fees from CDX diagnostics. The other authors declared to have no disclosures.
Publisher Copyright:
© 2022. The Author(s).
PY - 2023
Y1 - 2023
N2 - BACKGROUND: Current surveillance for Barrett's esophagus (BE), consisting of four-quadrant random forceps biopsies (FBs), has an inherent risk of sampling error. Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). In this multicenter randomized trial, we aimed to evaluate WATS as a substitute for FB.METHODS: Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice versa. All WATS samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Diagnostics laboratory. Similarly, all FBs were examined by two expert pathologists. The primary end point was concordance/discordance for detection of HGD/EAC between the two techniques.RESULTS: 172 patients were included, of whom 21 had HGD/EAC detected by both modalities, 18 had HGD/EAC detected by WATS but missed by FB, and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB (P = 0.36). Using WATS as an adjunct to FB significantly increased the detection of HGD/EAC vs. FB alone (absolute increase 10 % [95 %CI 6 % to 16 %]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95 %CI 5.9 to 7.1), 4.9 (95 %CI 4.1 to 5.4), and 11.2 (95 %CI 10.5 to 14.0), respectively.CONCLUSIONS: Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for the detection of HGD/EAC as single modality.
AB - BACKGROUND: Current surveillance for Barrett's esophagus (BE), consisting of four-quadrant random forceps biopsies (FBs), has an inherent risk of sampling error. Wide-area transepithelial sampling (WATS) may increase detection of high grade dysplasia (HGD) and esophageal adenocarcinoma (EAC). In this multicenter randomized trial, we aimed to evaluate WATS as a substitute for FB.METHODS: Patients with known BE and a recent history of dysplasia, without visible lesions, at 17 hospitals were randomized to receive either WATS followed by FB or vice versa. All WATS samples were examined, with computer assistance, by at least two experienced pathologists at the CDx Diagnostics laboratory. Similarly, all FBs were examined by two expert pathologists. The primary end point was concordance/discordance for detection of HGD/EAC between the two techniques.RESULTS: 172 patients were included, of whom 21 had HGD/EAC detected by both modalities, 18 had HGD/EAC detected by WATS but missed by FB, and 12 were detected by FB but missed by WATS. The detection rate of HGD/EAC did not differ between WATS and FB (P = 0.36). Using WATS as an adjunct to FB significantly increased the detection of HGD/EAC vs. FB alone (absolute increase 10 % [95 %CI 6 % to 16 %]). Mean procedural times in minutes for FB alone, WATS alone, and the combination were 6.6 (95 %CI 5.9 to 7.1), 4.9 (95 %CI 4.1 to 5.4), and 11.2 (95 %CI 10.5 to 14.0), respectively.CONCLUSIONS: Although the combination of WATS and FB increases dysplasia detection in a population of BE patients enriched for dysplasia, we did not find a statistically significant difference between WATS and FB for the detection of HGD/EAC as single modality.
KW - Surveillance
U2 - 10.1055/a-1949-9542
DO - 10.1055/a-1949-9542
M3 - Article
C2 - 36150646
SN - 0013-726X
VL - 55
SP - 303
EP - 310
JO - Endoscopy
JF - Endoscopy
IS - 04
ER -