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DOI: 10.1055/s-0039-1681505
HIGH DEFINITION WHITE-LIGHT COLONOSCOPY VERSUS CHROMOENDOSCOPY FOR SURVEILLANCE OF LYNCH SYNDROME. A MULTICENTER, RANDOMIZED, PARALLEL, AND NON-INFERIORITY STUDY (ENDOLYNCH STUDY)
Publication History
Publication Date:
18 March 2019 (online)
Aims:
Adenomas in Lynch syndrome (LS) have an accelerated progression to colorectal cancer. Despite low evidence, clinical guidelines recommend using high-definition and pan-chromoendoscopy (CE) for surveillance in LS. We aimed to compare the adenoma detection rate (ADR) between high-definition white-light endoscopy (WLE) and CE in individuals with LS.
Methods:
Multicenter, randomized and parallel study with high-level detector endoscopists, devoted to high-risk conditions of colorectal cancer. Adults with confirmed mutation (MLH1, MSH2, MSH6, PMS2 and Epcam) were randomized 1:1 to WLE or CE. 244 individuals were required to demonstrate non-inferiority of WLE versus CE (non-inferiority margin of 15%; power 80%; drop-out 10%; significance of 0.025).
Results:
256 subjects were included by 14 Spanish centers. Baseline characteristics (demographic, medical history, genotype) were similar between groups. The ADR for WLE versus CE were 28.1% (95% confidence interval 21.1%-36.4%) versus 34.4% (26.4%-43.3%) respectively (p = 0.281). The detection rate of lesions in WLE versus CE group were as follow: polyps 50.0% versus 57.7% (p = 0.004), serrated lesions 23.4% versus 37.5% (p = 0.015), proximal serrated lesions 10.2% versus 11.7% (p = 0.689), sessile serrated lesions 5.5% versus 3.9% (p = 0.554) and advanced adenomas 7.8% versus 3.9% (p = 0.183) respectively. The mean (± standard deviation) of lesions per patient for WLE versus CE were as follow: adenomas 1.04 (1.37) versus 0.86 (1.04) (p = 0.670), polyps 2.36 (1.77) versus 2.67 (2.29) (p = 0.004), serrated lesions 0.67 (0.89) versus 1.04 (1.38) (p = 0.004), proximal serrated lesions 0.25 (0.56) versus 0.25 (0.61) (p = 0.426), sessile serrated lesions 0.10 (0.31) versus 0.11 (0.67) (p = 0.660) respectively. The total procedural time and withdrawal time (mean ± standard deviation; in minutes) with WLE versus CE were as follow: 22.42 ± 8.72 versus 30.67 ± 12.84 (p < 0.001) and 13.5 ± 5.63 versus 18.37 ± 7.57 (p < 0.001) respectively.
Conclusions:
In a scenario with high-level detector endoscopists, high-definition WLE is an optimal and efficient endoscopic technique for surveillance of LS. CE prolonged the procedural time without increasing detection of relevant lesions.
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