New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study),Gastrointestinal Endoscopy

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New-generation full-spectrum endoscopy versus standard forward-viewing colonoscopy: a multicenter, randomized, tandem colonoscopy trial (J-FUSE Study)
Gastrointestinal Endoscopy ( IF 6.7 ) Pub Date : 2018-06-13 , DOI: 10.1016/j.gie.2018.06.011
Toyoki Kudo , Yutaka Saito , Hiroaki Ikematsu , Kinichi Hotta , Yoji Takeuchi , Masaaki Shimatani , Ken Kawakami , Naoto Tamai , Yuichi Mori , Yasuharu Maeda , Masayoshi Yamada , Taku Sakamoto , Takahisa Matsuda , Kenichiro Imai , Sayo Ito , Kenta Hamada , Norimasa Fukata , Takuya Inoue , Hisao Tajiri , Kenichi Yoshimura , Hideki Ishikawa , Shin-ei Kudo

Background and Aims

Although colonoscopy is the criterion standard for detection of colorectal adenomas, some adenomas are missed. Full-spectrum endoscopy (FUSE) allows for observation with a 330-degree angle of view, which is expected to decrease the miss rate. However, no consensus has been reached regarding the superiority of FUSE over standard forward-viewing colonoscopy (SFVC) for detection of adenomas; we therefore compared new-generation FUSE and SFVC regarding colorectal adenoma miss rate (AMR) in this, the first reported randomized control trial using new-generation FUSE.

Methods

We enrolled individuals aged 40 to 75 years who had been referred for screening, surveillance, fecal occult blood test positivity, or symptoms in a prospective randomized trial of tandem colonoscopy in 8 institutions. Patients were randomly assigned (1:1) via computer-generated stratified randomization. Neither the endoscopists nor patients were blinded to the allocation. The primary endpoint was AMR per patient (AMR-PP).

Results

We enrolled 345 patients and included 319 in the per-protocol analyses. AMR-PP was significantly lower with FUSE (11.7%; 95% confidence interval [CI], 8.0%-15.4%) than with SFVC (22.9%; 95% CI, 17.5%-28.3%; P < .001). AMR-PP for lesions ≤5 mm in size was significantly lower with FUSE (10.4%; 95% CI, 6.5%-14.3%) than with SFVC (20.0%; 95% CI, 14.4%-25.6%; P = .0057). Furthermore, AMR-PP in the ascending colon was significantly lower with FUSE (4.3%; 95% CI, 1.4%-7.2%) than with SFVC (10.6%; 95% CI, 6.1%-15.1%; P = .0212).

Conclusions

FUSE is superior to SFVC regarding both AMR-PP and AMR; additionally, AMR-PP is both significantly lower with FUSE than SFVC for lesions ≤5 mm in size and in the ascending colon. (Clinical trial registration number: UMIN000020448.)

中文翻译：

新一代全光谱内窥镜与标准前视结肠镜：一项多中心，随机，串联结肠镜试验（J-FUSE研究）

背景和目标

尽管结肠镜检查是检测结直肠腺瘤的标准标准，但仍缺少一些腺瘤。全光谱内窥镜（FUSE）允许以330度的视角进行观察，这有望降低漏检率。然而，就检测腺瘤而言，FUSE优于标准前瞻性结肠镜检查（SFVC）尚无共识。因此，我们在此比较了大肠腺瘤缺失率（AMR）方面的新一代FUSE和SFVC，这是首次报道的使用新一代FUSE的随机对照试验。

方法

我们在8个机构的一项前瞻性随机结肠镜检查随机试验中纳入了40至75岁的个体，这些个体被转诊至筛查，监测，粪便潜血试验阳性或症状。通过计算机生成的分层随机分组将患者随机分配（1：1）。内镜医师和患者均不盲目分配。主要终点是每位患者的AMR（AMR-PP）。

结果

我们招募了345名患者，并在每项协议分析中包括319名患者。FUSE（11.7％; 95％置信区间[CI]，8.0％-15.4％）的AMR-PP显着低于SFVC（22.9％; 95％CI，17.5％-28.3％; P <.001）。对于FUSE（10.4％; 95％CI，6.5％-14.3％），对于尺寸≤5mm病变的AMR-PP显着低于SFVC（20.0％; 95％CI，14.4％-25.6％; P = .0057 ）。此外，FUSE（4.3％; 95％CI，1.4％-7.2％）的升结肠中的AMR-PP显着低于SFVC（10.6％; 95％CI，6.1％-15.1％; P = .0212）。