渐进式硬度与磁共振成像引导的可变硬度结肠镜：一项随机非劣效性试验。

Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial.

作者信息

Garborg Kjetil, Wiig Håvard, Hasund Audun, Matre Jon, Holme Øyvind, Noraberg Geir, Løberg Magnus, Kalager Mette, Adami Hans-Olov, Bretthauer Michael

机构信息

Department of Medicine, Sorlandet Hospital, Kristiansand, Norway; Department of Transplantation Medicine, Section of Gastroenterology, Oslo University Hospital, Norway; Department of Health Economy and Health Management and KG Jebsen Center of Colorectal Cancer Research, University of Oslo, Norway.

Department of Medicine, Sorlandet Hospital, Kristiansand, Norway.

出版信息

United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.

DOI:10.1177/2050640616639162

PMID:28405331

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5384545/

Abstract

BACKGROUND

Colonoscopes with gradual stiffness have recently been developed to enhance cecal intubation.

OBJECTIVE

We aimed to determine if the performance of gradual stiffness colonoscopes is noninferior to that of magnetic endoscopic imaging (MEI)-guided variable stiffness colonoscopes.

METHODS

Consecutive patients were randomized to screening colonoscopy with Fujifilm gradual stiffness or Olympus MEI-guided variable stiffness colonoscopes. The primary endpoint was cecal intubation rate (noninferiority limit 5%). Secondary endpoints included cecal intubation time. We estimated absolute risk differences with 95% confidence intervals (CIs).

RESULTS

We enrolled 475 patients: 222 randomized to the gradual stiffness instrument, and 253 to the MEI-guided variable stiffness instrument. Cecal intubation rate was 91.7% in the gradual stiffness group versus 95.6% in the variable stiffness group. The adjusted absolute risk for cecal intubation failure was 4.3% higher in the gradual stiffness group than in the variable stiffness group (upper CI border 8.1%). Median cecal intubation time was 13 minutes in the gradual stiffness group and 10 minutes in the variable stiffness group ( < 0.001).

CONCLUSIONS

The study is inconclusive with regard to noninferiority because the 95% CI for the difference in cecal intubation rate between the groups crosses the noninferiority margin. (ClinicalTrials.gov identifier: NCT01895504).

摘要

背景

最近开发了具有渐变硬度的结肠镜以提高盲肠插管率。

目的

我们旨在确定渐变硬度结肠镜的性能是否不劣于磁内镜成像（MEI）引导的可变硬度结肠镜。

方法

连续的患者被随机分配接受富士胶片渐变硬度结肠镜或奥林巴斯MEI引导的可变硬度结肠镜的筛查结肠镜检查。主要终点是盲肠插管率（非劣效性界限为5%）。次要终点包括盲肠插管时间。我们估计了具有95%置信区间（CI）的绝对风险差异。

结果

我们纳入了475例患者：222例随机分配至渐变硬度器械组，253例随机分配至MEI引导的可变硬度器械组。渐变硬度组的盲肠插管率为91.7%，可变硬度组为95.6%。渐变硬度组盲肠插管失败的校正绝对风险比可变硬度组高4.3%（CI上限8.1%）。渐变硬度组的中位盲肠插管时间为13分钟，可变硬度组为10分钟（<0.001）。