Svein Olav Bratlie1, Erik Johnsson2, Claes Jönsson2, Lars Fändriks2, Anders Edebo2. 1. Department of Gastrosurgical Research, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: svein.olav.bratlie@vgregion.se. 2. Department of Gastrosurgical Research, Sahlgrenska University Hospital, Gothenburg, Sweden.
Abstract
BACKGROUND & AIMS: Surveillance of patients with Barrett's esophagus usually is performed with standard white-light endoscopy (SDWLE) and the collection of 4 biopsy specimens (every 1-2 cm of the metaplastic segment), based on Seattle protocol. New endoscopic techniques are used routinely, but have been validated based only on low-grade evidence. We aimed to validate the use of high-definition magnifying endoscopy with multiple-band imaging (HDMEMBI) with a targeted biopsy collection for the detection of dysplasia, using SDWLE with quadrant biopsy collection as the reference. METHODS: In a cross-over study, patients with suspected or histologically verified BE (without known neoplasia) seen at a tertiary referral high-volume endoscopy center in Sweden, from November 2009 through November 2012, were assigned randomly to undergo HDMEMBI (n = 63) or SDWLE (n = 47) as the initial procedure, followed by the other procedure in 1 to 4 months. The primary end point was the total number of subjects found to have low-grade dysplasia or high-grade dysplasia (HGD) by each technique. Secondary end points included the number of biopsy specimens taken and the duration of each procedure. RESULTS: There was no significant difference between groups in diagnostic yield for low-grade dysplasia (14 in HDMEMBI vs. 13 in SDWLE) or HGD. Four HGDs were found: 3 using HDMEMBI and 1 using SDWLE. Significantly fewer biopsy specimens were collected during the HDMEMBI procedure (P < .001). The diagnostic yield for the detection of dysplasia per biopsy specimen collected therefore was significantly higher for HDMEMBI than SDWLE (0.25 vs. 0.07; P = .018). There was no significant difference in the duration of procedures. CONCLUSIONS: There is no significant difference in the detection of dysplastic lesions using HDMEMBI with targeted collection of biopsy specimens vs SDWLE with 4-quadrant biopsy specimen collection. However, HDMEMBI requires the collection of significantly fewer biopsy specimens, providing better value for health care providers. ClinicalTrials.gov number: NCT01694511.
RCT Entities:
BACKGROUND & AIMS: Surveillance of patients with Barrett's esophagus usually is performed with standard white-light endoscopy (SDWLE) and the collection of 4 biopsy specimens (every 1-2 cm of the metaplastic segment), based on Seattle protocol. New endoscopic techniques are used routinely, but have been validated based only on low-grade evidence. We aimed to validate the use of high-definition magnifying endoscopy with multiple-band imaging (HDMEMBI) with a targeted biopsy collection for the detection of dysplasia, using SDWLE with quadrant biopsy collection as the reference. METHODS: In a cross-over study, patients with suspected or histologically verified BE (without known neoplasia) seen at a tertiary referral high-volume endoscopy center in Sweden, from November 2009 through November 2012, were assigned randomly to undergo HDMEMBI (n = 63) or SDWLE (n = 47) as the initial procedure, followed by the other procedure in 1 to 4 months. The primary end point was the total number of subjects found to have low-grade dysplasia or high-grade dysplasia (HGD) by each technique. Secondary end points included the number of biopsy specimens taken and the duration of each procedure. RESULTS: There was no significant difference between groups in diagnostic yield for low-grade dysplasia (14 in HDMEMBI vs. 13 in SDWLE) or HGD. Four HGDs were found: 3 using HDMEMBI and 1 using SDWLE. Significantly fewer biopsy specimens were collected during the HDMEMBI procedure (P < .001). The diagnostic yield for the detection of dysplasia per biopsy specimen collected therefore was significantly higher for HDMEMBI than SDWLE (0.25 vs. 0.07; P = .018). There was no significant difference in the duration of procedures. CONCLUSIONS: There is no significant difference in the detection of dysplastic lesions using HDMEMBI with targeted collection of biopsy specimens vs SDWLE with 4-quadrant biopsy specimen collection. However, HDMEMBI requires the collection of significantly fewer biopsy specimens, providing better value for health care providers. ClinicalTrials.gov number: NCT01694511.