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临床试验/NCT06059378
NCT06059378招募中不适用

Using Artificial Intelligence-assisted Optical Polyp Diagnosis for Diminutive Colorectal Polyps

Daniel Von Renteln1 个研究点 分布在 1 个国家目标入组 204 人开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
204
试验地点
1
主要终点
Accuracy of the intracolonoscopy AI-assisted optical diagnosis

研究概览

简要总结

This is a prospective study that is the first to implement resect and discard and diagnose and leave strategies in real-time practice using stringent documentation and adjudication by 2 expert endoscopists as the gold standard.

The primary aim of this study is to show the accuracy of intracolonoscopy AI-assisted optical diagnosis (CADx; autonomous or with human input) when the AI-assisted optical diagnosis made by the expert endoscopists is used as the reference standard. The specific aims are:

  1. To evaluate the accuracy of intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) by comparing it to the obtained optical histology diagnoses provided by two independent expert endoscopists as the reference standard.
  2. To evaluate the agreement between the intracolonoscopy AI-assisted optical polyp diagnosis (autonomous or with human input) and the AI-assisted optical diagnosis performed by two independent expert endoscopists.
  3. To determine whether AI-assisted optical polyp diagnosis for diminutive (1-5 mm) polyps can be implemented in routine clinical practice by demonstrating that at least 70% of the approached patients are interested in undergoing AI-assisted optical diagnosis (autonomous or with human input).
  4. To evaluate the cost savings resulting from replacing pathology with AI-assisted optical diagnosis.

详细描述

All patients who meet the inclusion criteria can be enrolled. Eligible patients will be informed about the study through a consent form that includes information on optical diagnosis (resect and discard, diagnose and leave) and AI/CADx systems. We will ask the patients' willingness to undergo AI-assisted optical diagnosis with endoscopists' input (the first 102 patients) and automomous AI-assisted optical diagnosis (from patient 103 to 204). Subsequently, patients will be asked if they are willing to participate in the study, using AI-assisted optical diagnosis and the "resect and discard" and "diagnose and leave" strategy. If a patient declines to undergo optical diagnosis, they will be asked about the reason for their refusal to participate in the study. The options for their response include:

  1. Concerns regarding undergoing an optical diagnosis.
  2. Reluctance to participate in research projects in general.
  3. Other reasons.
  4. Preference not to answer the question.

Patients who agree to participate in the study will undergo standard colonoscopy procedures with AI-assisted optical diagnosis for all diminutive colorectal polyps identified. High-definition colonoscopes with a joint computer-assisted classification (CADx) support (CAD-EYE software EW10-EC02) will be used.

For the first 102 patients (i.e., the CAD-assisted optical diagnosis with endoscopist's input), the endoscopists will use the CAD-EYE blue light imaging (BLI) mode to enhance the visualization of polyp features. During the optical diagnosis using CADx, the most probable diagnosis (neoplastic or hyperplastic) will be displayed on the endoscopy screen. If the serrated pathology subtype is determined as the most probable histology, the endoscopists will make the final decision. They will also indicate whether their optical diagnosis was made with low or high confidence.

For the second group of 102 patients (i.e., autonomous CADx-assisted optical diagnosis), endoscopists will use CADx and BLI mode to perform optical diagnosis. Based on the CADx diagnosis, all 1-5 mm polyps diagnosed as hyperplastic or neoplastic will be resected and discarded, while those located in the rectosigmoid and diagnosed as hyperplastic will be left in the colon. When high-risk histology features are observed using BLI, in any patient, the endoscopists will inform the research assistant to document them, and the polyp will be sent for pathology examination in accordance with the ASGE PIVI guidelines recommendations. All polyps >5mm will be send for pathology evaluation. Polyp size will be measured using virtual scale technology integrated in the computer-assisted system (CAD) to ensure an accurate polyp sizing.18 A research assistant will document the characteristics of the detected polyps (i.e., location, size, morphology, AI-assisted intracolonoscopy and endoscopists optical diagnoses). All identified colorectal polyps will be removed following standard polypectomy practices. The entire colonoscopy procedures will be video recorded for quality assurance purposes. All diminutive polyps will be resected and discarded as part of the resect and discard strategy. Additionally, diminutive polyps located in the rectosigmoid colon will be detected and left in situ (diagnose and leave strategy) if no high-risk features are present.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45-80 years
  • Undergoing an outpatient colonoscopy at the Centre Hospitalier de l'Université de Montréal (CHUM)
  • Signed informed consent form

排除标准

  • Inflammatory Bowel Disease;
  • Active colitis;
  • Hereditary CRC syndrome;
  • Coagulopathy;
  • American Society of Anesthesiologists (ASA) status >3

结局指标

主要结局

Accuracy of the intracolonoscopy AI-assisted optical diagnosis

时间窗: 120 days

Using the optical diagnosis obtained from 2 experts as the reference, the accuracy of the intracolonoscopy AI-assisted optical diagnosis (OD, with endoscopist input or autonomous) is measured as the number of correct ODs out of all ODs (%).

次要结局

  • Proportion of patients who accept study participation(120 days)
  • Proportion of the patients unwilling to participate due to concerns regarding undergoing an optical diagnosis(120 days)
  • Agreement between the intracolonoscopy AI-assisted optical diagnosis and the AI-assisted optical diagnosis by experts(120 days)
  • Diagnostic characteristics of AI-assisted optical diagnosis using adjudication by two expert endoscopists as the reference standard(120 days)
  • Proportion of polyps with a low-confidence diagnosis(120 days)
  • Assessing cost savings through AI-assisted optical diagnosis(120 days)

研究者

发起方
Daniel Von Renteln
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniel Von Renteln

Gastroenterologist, MD

Centre hospitalier de l'Université de Montréal (CHUM)

研究点 (1)

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