Department of Gastroenterology and Hepatology, Academic Medical Centre, Amsterdam, Netherlands.
Tees Bowel Cancer Screening Centre, University Hospital of North Tees, Stockton-on-Tees, Cleveland, UK; Newcastle University, Newcastle-upon-Tyne, UK.
Lancet Gastroenterol Hepatol. 2018 May;3(5):305-316. doi: 10.1016/S2468-1253(18)30055-4. Epub 2018 Mar 20.
Patients with longstanding ulcerative colitis undergo regular dysplasia surveillance because they have an increased colorectal cancer risk. Autofluorescence imaging and chromoendoscopy improve dysplasia detection. The aim of this study was to determine whether autofluorescence imaging should be further studied as an alternative method for dysplasia surveillance in patients with longstanding ulcerative colitis.
This prospective, international, randomised controlled trial included patients from an ulcerative colitis-dysplasia surveillance cohort from five centres in the Netherlands and the UK. Eligible patients were aged 18 years or older who were undergoing dysplasia surveillance after being diagnosed with extensive colitis (Montreal E3) at least 8 years before study start or with left-sided colitis (Montreal E2) at least 15 years before study start. Randomisation (1:1) was minimised for a previous personal history of histologically proven dysplasia and concomitant primary sclerosing cholangitis. The coprimary outcomes were the proportion of patients in whom at least one dysplastic lesion was detected and the mean number of dysplastic lesions per patient. The relative dysplasia detection rate, calculated as the ratio of the detection rates by autofluorescence imaging and chromoendoscopy, needed to be more than 0·67 (using an 80% CI) for both primary outcomes to support a subsequent large non-inferiority trial. Outcomes were analysed on a per-protocol basis. The trial is registered at the Netherlands Trial Register, number NTR4062.
Between Aug 1, 2013, and March 10, 2017, 210 patients undergoing colonoscopy surveillance for longstanding ulcerative colitis were randomised for inspection with either autofluorescence imaging (n=105) or chromoendoscopy (n=105). Dysplasia was detected in 13 (12%) patients by autofluorescence imaging and in 20 patients (19%) by chromoendoscopy. The relative dysplasia detection rate of autofluorescence imaging versus chromoendoscopy for the proportion of patients with ulcerative colitis with at least one dysplastic lesion was 0·65 (80% CI 0·43-0·99). The mean number of detected dysplastic lesions per patient was 0·13 (SD 0·37) for autofluorescence imaging and 0·37 (1·02) for chromoendoscopy (relative dysplasia detection rate 0·36, 80% CI 0·21-0·61). Adverse events were reported for two patients in the autofluorescence imaging group (one patient had intraprocedural mild bleeding, and one patient had abdominal pain) and for three patients in the chromoendoscopy group (two patients had intraprocedural mild bleeding, and one patient had perforation).
Autofluorescence imaging did not meet criteria for proceeding to a large non-inferiority trial. Therefore, existing autofluorescence imaging technology should not be further investigated as an alternative dysplasia surveillance method.
Olympus Europe and Olympus Keymed.
患有长期溃疡性结肠炎的患者需要定期进行异型增生监测，因为他们的结直肠癌风险增加。自体荧光成像和染色内镜可提高异型增生的检出率。本研究旨在确定自体荧光成像是否应进一步研究作为长期溃疡性结肠炎患者异型增生监测的替代方法。
这是一项前瞻性、国际、随机对照试验，纳入了来自荷兰和英国五个中心的溃疡性结肠炎异型增生监测队列中的患者。符合条件的患者年龄在 18 岁及以上，在研究开始前至少 8 年被诊断为广泛性结肠炎（蒙特利尔 E3）或至少 15 年被诊断为左侧结肠炎（蒙特利尔 E2）后正在接受异型增生监测。采用最小化设计对先前有组织学证实的异型增生病史和同时存在原发性硬化性胆管炎的患者进行 1:1 随机分组。主要结局是至少检出一个异型增生病变的患者比例和每位患者的异型增生病变平均数量。如果自体荧光成像和染色内镜的检测率之比大于 0.67（90%置信区间），则支持随后进行非劣效性大型试验，这两个主要结局需要达到该比值。根据意向治疗原则进行结果分析。该试验在荷兰试验注册中心注册，编号为 NTR4062。
2013 年 8 月 1 日至 2017 年 3 月 10 日期间，210 例接受长期溃疡性结肠炎结肠镜监测的患者被随机分为接受自体荧光成像（n=105）或染色内镜（n=105）检查。通过自体荧光成像发现 13 例（12%）患者有异型增生，通过染色内镜发现 20 例（19%）患者有异型增生。自体荧光成像与染色内镜相比，至少有一个异型增生病变的溃疡性结肠炎患者比例的相对异型增生检出率为 0.65（90%置信区间 0.43-0.99）。每位患者的平均异型增生病变检出数为自体荧光成像 0.13（标准差 0.37），染色内镜 0.37（1.02）（相对异型增生检出率 0.36，90%置信区间 0.21-0.61）。在自体荧光成像组报告了两名患者的不良事件（一名患者术中轻度出血，一名患者腹痛），在染色内镜组报告了三名患者的不良事件（两名患者术中轻度出血，一名患者穿孔）。
自体荧光成像未达到进行大型非劣效性试验的标准。因此，不应进一步研究现有的自体荧光成像技术作为异型增生监测的替代方法。
奥林巴斯欧洲公司和奥林巴斯基梅德公司。
