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临床试验/NCT04899700
NCT04899700已完成不适用

Linked Color Imaging vs. High-definition White Light Endoscopy for the Evaluation of Post-polypectomy Scars of Non-pedunculated Polyps. A Randomized Controlled Cross-over Trial. (LCI-Scar Study).

Hospital Clinic of Barcelona2 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2020年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
173
试验地点
2
主要终点
Number of recurrence on postpolypectomy scars with LCI

研究概览

简要总结

Careful inspection and evaluation of the post-polipectomy scars of polyps greater than 20 mm looking for residual polyp is mandatory. LCI has demonstrated to improve polyp and adenoma detection rate in previous studies. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. So, our aim is to compare the efficacy of linked color imaging for optical diagnosis of post-polypectomy scar recurrence compared with high-definition white light endoscopy.

详细描述

Polypectomy is highly effective in reducing cancer risk by resection of colon cancer precursors: adenomas and serrated lesions1. Despite expertise and good technique, up to 20% of non-pedunculated colorectal polyps larger than 20 mm resected by piecemeal endoscopic mucosal resection (EMR) show scar recurrence2. High recurrence rate implies a higher burden of subsequent surveillance and therapeutic colonoscopies, resulting in patient medicalization and increased costs.

Careful inspection and evaluation of the post-polipectomy scars looking for residual polyp is mandatory. In the past few years several techniques have been developed to improve optical diagnosis. One of them, virtual chromoendoscopy have been developed to overcome laboriousness of conventional chromoendoscopy. A recently a well-designed randomized controlled trial has demonstrated the accuracy of high definition white light endoscopy (WLE) and narrow band imaging (NBI) with or without magnification for diagnosis of scar recurrence after an endoscopic mucosal resection3. High diagnostic values were found for all the modalities but the diagnosis accuracy was higher in NBI with near focus. In cases of high confidence, if the optical diagnosis with NBI plus near focus for scar recurrence is negative, no biopsies are needed3. In view of these findings, the European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of virtual or dye-based chromoendoscopy in addition to WLE for the detection of residual neoplasia in the polypectomy scar after a piecemeal resection.

Fujifilm® (HDTV, ELUXEOTM 700 System, Fujifilm® Tokyo, Japan) has developed a new generation of electronic endoscopy system that employs 4 different-wavelength LEDs as light sources. By changing the intensity of each of 4 LEDs, a white light mode and a Linked Color Imaging (LCI) and Blue Light Imaging (BLI) mode can be obtained. The white light mode is similar to conventional endoscopy using a Xenon lamp while LCI and BLI are the new technologies incorporated the system allowing a bright image-enhanced chromoendoscopy. In both BLI and LCI mode, the peak intensity of the LEDs is set at 410nm±10nm. As this is the peak absorption of light of hemoglobin, microvascular structures at the surface of the mucosa can be distinguished more clearly from blood vessels in the deep mucosa. In contrast to BLI, LCI also acquires the white light in an appropriate balance. The acquired color information is reallocated to differentiate the colors close to the mucosal color, i.e. information for several colors is simultaneously expanded so that the reddish and whitish colors become redder and whiter, respectively. Thereby, mucosal surface patterns are better visualized and this could potentially increase the detection of polyps by improving the visibility of colorectal lesions.

LCI has demonstrated to improve polyp and adenoma detection rate in previous studies5-7. However, to our knowledge no previous studies have been made for validation of LCI for optical diagnosis of a scar looking for residual neoplasia after a previous polypectomy. We hypothesize that LCI will improve the optical diagnosis of polyp recurrence compared to WLE. Therefore, the aim of this study is to evaluate the efficacy of LCI for optical diagnosis of post-polypectomy scar recurrence compared with WLE.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Any patient ≥18 years undergoing surveillance colonoscopy after a previous polypectomy of one or more non-pedunculated polyps greater than 15 mm.
  • •Provide informed consent.

排除标准

  • •Inflamatory bowel disease

研究组 & 干预措施

WLE-LCI

Placebo Comparator

First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with WLE. Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)

干预措施: Linked Color Imaging (Device)

WLE-LCI

Placebo Comparator

First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with WLE. Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)

干预措施: White light endoscopy (Other)

LCI-WLE

Active Comparator

First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with Linked Color Imaging (LCI). Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)

干预措施: Linked Color Imaging (Device)

LCI-WLE

Active Comparator

First endoscopist will perform an optical diagnosis of recurrence of post-polypectomy scar with Linked Color Imaging (LCI). Then a second diagnosis will be performed by the same endoscopist with blue light imaging (BLI)

干预措施: White light endoscopy (Other)

结局指标

主要结局

Number of recurrence on postpolypectomy scars with LCI

时间窗: 2 years

Number of recurrence on postpolypectomy scars detected with AI

时间窗: 2 years

Number of recurrence on postpolypectomy scars with White light endoscopy

时间窗: 2 years

次要结局

  • Elapsed time(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María Pellisé

María Pellisé

Hospital Clinic of Barcelona

研究点 (2)

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