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临床试验/NCT03843567
NCT03843567Unknown不适用

A Randomised Controlled Trial of the Prediction of Diminutive/Small Polyp Histology: a Comparison Between Didactic Training Versus Self-directed Computer Based Training

University of Birmingham0 个研究点目标入组 160 人开始时间: 2019年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
160
主要终点
Ability to predict colorectal polyp histology

研究概览

简要总结

Bowel cancer is one of the most common cancers and the best method of diagnosing it is through endoscopic examination of the bowel (colonoscopy). Pre-cursors of bowel cancer are called polyps which can be detected and removed at the time of the colonoscopy. This reduces the chance of developing bowel cancer. There are different types of polyp ranging from completely harmless to those that may develop into cancer over time.

Advances in technology mean more polyps are being detected and it is possible to predict the type of polyp. Therefore there is a new strategy in endoscopy whereby when a small polyp is detected, a prediction of polyp type is made, the polyp removed and then discarded rather than sending to the laboratory, thereby reducing costs to health services.

In the hands of experts, accuracies in predicting polyp type is similar to when the polyp is removed and sent to the lab for analysis. Whilst experts can do this, non-experts cannot reach these standards and there is a need for effective training.

The aim of the study is to compare the effectiveness of two training methods: Didactic face-to-face training and computer-based self-learning on the ability of trainees at predicting polyp type.

详细描述

Colonoscopy is the gold standard for screening for bowel cancers and detection of pre-cursors to colorectal cancer (polyps). Early detection of polyps, allows endoscopic removal and therefore reduction in colorectal cancer. With improvements in technology endoscopists are detecting more lesions within the bowel with the majority small/diminutive <5mm (80%), however the clinical relevance of these lesions is minimal as the risk of advanced histology or cancer is <1%. The current practice involves removing these lesions and sending for histopathological assessment, incurring a significant risk to the patient, cost and is time-consuming, with very little benefit. Novel imaging techniques including Narrow-band imaging (NBI-Olympus, Japan), i-Scan Optical enhancement (OE-Pentax, Japan) and Blue-light laser imaging (BLI- Fujifilm, Japan) can help endoscopists characterise these small lesions between being neoplastic and non-neoplastic (hyperplastic). NBI involves the narrowing of bandwidths of light using a light filter. The light at this end of the spectrum is absorbed by haemoglobin (protein found within blood) therefore making blood vessels more pronounced. During the process whereby a polyp develops and later becomes neoplastic, there is an increase in blood vessels compared with normal tissue or hyperplastic polyps (benign), therefore NBI can be used to detect such lesions. I-Scan OE is an alternative imaging technique which enhances the pattern of the surface of polyps as well as the blood vessels, by manipulating dark-light borders and red, blue and green components of light. Blue laser imaging (BLI) is also new system for image-enhanced endoscopy using laser light. Blue laser imaging utilizes two monochromatic lasers (410 and 450 nm) instead of xenon light. A 410 nm laser visualizes vascular microarchitecture, similar to narrow band imaging, and a 450 nm laser provides white light by excitation.

These novel technologies have been demonstrated to be superior over standard white light endoscopy with NBI the most extensively investigated. A systematic analysis of 6 studies >500 polyps, resulted in a pooled sensitivity of 92%, spec 86%, accuracy of 89% at differentiating neoplastic from non-neoplastic lesions when using NBI. Head to head studies of NBI versus white light endoscopy (WLE) have shown NBI is better at differentiating between neoplastic and non-neoplastic lesions. Similar results have been found with i-Scan, with performances better than WLE and like NBI are similar to chromoendoscopy (a technique that involves spraying dye over bowel mucosa which is time-consuming and costly). BLI is a newer imaging platform, with the current evidence suggesting it is effective at differentiating polyps (neoplastic versus non-neoplastic) with accuracies of 95.2%, and when comparing with white light endoscopy the miss rate of adenoma was significantly lower with BLI (1.6% versus 10.0% p=0.001).

In order to characterise between neoplastic and non-neoplastic lesions, endoscopic scoring systems have been developed to assist endoscopists. Examples include NICE (NBI International Colorectal Endoscopic).

Recently Iacucci et al have developed a simplified classification system (SIMPLE- Simplified Identification Method for Polyp Labelling during the Endoscopy) for optical diagnosis of small and diminutive adenomas, SSA/Ps and hyperplastic polyps using the newly introduced OE-iSCAN system which achieved a high degree of diagnostic accuracy for small/diminutive polyp diagnosis. Furthermore, they have showed that a training module on SIMPLE classification resulted in an overall NPV of 91.3%. This user-friendly classification system can be used by experienced and non-experienced gastroenterologists on multiple endoscopy imaging platforms to differentiate neoplastic from non-neoplastic polyps. A classification system developed by Bisschops R et al recently using BLI called BASIC (BLI Adenoma Serrated International Classification). This takes into account the polyp surface, pit appearance and vessels, which has shown to have a high concordance amongst experts.

In the hands of experts using NBI-NICE classification system accuracies of 98.9%, sensitivity 98%, specificity 100%, NPV 97.7% and PPV100% were demonstrated when diagnosis was made with high confidence. Essential to the adopted use of these classifications is training for endoscopists, both experienced and those in training. There is good evidence that there is a short learning curve involved when using NBI. One study using a self-administered computer based training module, community based gastroenterologists (non-expert) were able to reach excellent NPV of >90% but fell short of other requirements (prediction of surveillance intervals). Much like NBI, the learning curve at acquiring the skills in order to differentiate between hyperplastic and adenomatous lesions using i-Scan has been investigated. An early study by Neumann et al demonstrated a rapid learning curve with 4 endoscopists without previous experience with i-scan reached an accuracy of at least 85% after reviewing 67-110 lesions (with individualised feedback) following a 1 hour teaching session on pit pattern analysis.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Training colonoscopists: gastroenterology trainee in the process of training in colonoscopy and have had some experience of colonoscopy.

排除标准

  • Inability to consent to take part in the study
  • Gastroenterology trainees without experience of colonoscopy

结局指标

主要结局

Ability to predict colorectal polyp histology

时间窗: 6 months

Accuracy of polyp prediction, sensitivity, specificity, positive predictive value and negative predictive value

次要结局

  • Interobserver agreement(6 months)
  • High confidence predictions(6 months)

研究者

申办方类型
Other
责任方
Sponsor

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