COLODETECT 1：在筛查结肠镜检查中，对比评估带计算机辅助检测的内镜袖口与单纯计算机辅助检测及标准结肠镜检查对提高腺瘤检出率的效果——一项初步研究
COLODETECT 1: comparative evaluation of endocuff with computer-aided detection versus computer-aided detection alone versus standard colonoscopy for enhancing adenoma detection rates during screening colonoscopy-a pilot study.
作者信息
Caillo Ludovic, Delliot Clément, Chevallier Thierry, Bourgaux Jean-Francois, Prost Ardavan, Brunaud-Gagniard Bénédicte, Phoutthasang Valérie, Clerc Clémentine, Borderie Thomas, Daniel Jules, Pouderoux Philippe, Debourdeau Antoine
机构信息
Department of Gastroenterology, Carémeau Hospital, University Hospital of Nîmes, Place du Professeur Robert Debre, Nîmes, Gard 30029, France.
Department of Gastroenterology, University Hospital of Nîmes, Nîmes, France.
出版信息
Therap Adv Gastroenterol. 2024 Oct 27;17:17562848241290433. doi: 10.1177/17562848241290433. eCollection 2024.
BACKGROUND
Independent use of artificial intelligence with computer-aided detection (CADe) and Endocuff Vision (ECV) has demonstrated enhanced adenoma detection rates (ADRs).
OBJECTIVE
Our pilot study aimed to define the necessary participant number for future randomized controlled trials (RCTs) by comparing the ADR of combined CADe + ECV against CADe alone and standard colonoscopy.
DESIGN
This single-center pilot study retrospectively analyzed a prospectively maintained database, where patients underwent screening colonoscopies sequentially by standard method, CADe alone, and then CADe + ECV.
METHOD
The allocation of the technique depended on the study period. Patients were randomly selected from the cohort to form three groups of 30 patients, with stratification based on factors influencing the ADR. The primary endpoint was the ADR.
RESULTS
From April to June 2021, 244 patients underwent screening colonoscopy. 198 were eligible, and after randomization, 90 patients were included across three groups (colonoscopy = 30, CADe = 30, CADe + ECV = 30). The ADR was higher in the CADe + ECV group compared to the CADe and colonoscopy groups: 60% versus 40%, and 30%, respectively ( = 0.03). The number of polyps ⩽3 mm detected was greater in the CADe + ECV group ( = 23) versus CADe ( = 7) and colonoscopy ( = 12) groups, respectively ( = 0.03). CADe + ECV identified more polyps in the cecum/right colon ( = 26) compared to CADe ( = 18) and colonoscopy ( = 12) groups ( = 0.04), and in the left colon/sigmoid ( = 14) compared to CADe ( = 5) and colonoscopy ( = 2) ( = 0.02).
CONCLUSION
These findings underscore the synergic potential of combining CADe with ECV to enhance ADR and enable us to perform sample size calculations for future RCTs.
REGISTRATION
Clinical Trials number: NCT05080088. Registration 06/06/2021.
背景
计算机辅助检测（CADe）和Endocuff Vision（ECV）独立使用已显示出腺瘤检出率（ADR）有所提高。
目的
我们的初步研究旨在通过比较CADe联合ECV与单独使用CADe以及标准结肠镜检查的ADR，来确定未来随机对照试验（RCT）所需的参与者数量。
设计
这项单中心初步研究回顾性分析了一个前瞻性维护的数据库，其中患者依次通过标准方法、单独使用CADe以及随后的CADe联合ECV进行筛查结肠镜检查。
方法
技术分配取决于研究时期。从队列中随机选择患者，根据影响ADR的因素进行分层，形成三组，每组30名患者。主要终点是ADR。
结果
2021年4月至6月，244例患者接受了筛查结肠镜检查。198例符合条件，随机分组后，三组共纳入90例患者（结肠镜检查组 = 30例，CADe组 = 30例，CADe联合ECV组 = 30例）。CADe联合ECV组的ADR高于CADe组和结肠镜检查组，分别为60%、40%和30%（P = 0.03）。CADe联合ECV组检测到的直径≤3 mm的息肉数量分别多于CADe组（7个）和结肠镜检查组（12个）（P = 0.03）。与CADe组（18个）和结肠镜检查组（12个）相比，CADe联合ECV组在盲肠/右半结肠发现的息肉更多（26个）（P = 0.04）；与CADe组（5个）和结肠镜检查组（2个）相比，在左半结肠/乙状结肠发现的息肉也更多（14个）（P = 0.02）。
结论
这些发现强调了将CADe与ECV联合使用以提高ADR的协同潜力，并使我们能够为未来的RCT进行样本量计算。
注册信息
临床试验编号：NCT05080088。注册日期：2021年6月6日。
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