跳至主要内容
临床试验/NCT05699954
NCT05699954已完成不适用

Assessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal Polyps

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 191 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
191
试验地点
1
主要终点
The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.

研究概览

简要总结

Colorectal cancer (CRC) is a leading cause of death in the Western world. It can be effectively prevented by removal of pre-malignant polyps during colonoscopy. Large (≥20mm) non-pedunculated colorectal polyps (LNPCPs) represent 2-3% of colorectal polyps and require special attention prior to treatment. If submucosal invasive cancer (SMI) is suspected, careful decision making is required to exclude features which unacceptably increase the risk of lymph node metastases and render local treatment (endoscopic) non-curative. Such patients require a multi-disciplinary approach and consideration of surgery +/- systemic therapy.

Unfortunately, current classification systems are complex, require extensive training and technology not available in the majority of non-tertiary hospitals. They are therefore underused leading to incorrect decision making and negative patient outcomes (e.g. piecemeal resection without the chance of endoscopic cure or unnecessary further procedures in referral centres with resultant surgery anyway or surgery for benign disease).

Studies from the field of psychology show that humans are often capable of making correct decision based on their Blink (first) impression. It is also suggested that this Blink impression is based on experience and training. This might suggest that experienced or specialist endoscopist are better at diagnosing SMI within colorectal polyp at Blink impression.

The investigators hypothesize that by training the Blink impression, endoscopist of varying experience are able to detect cancer within LNPCPs. This can be proven by assessing the Blink impression of endoscopist of varying experience regarding the presence of SMI within LNPCPs.

Increasing the accuracy of the determination of SMI within colon polyps would directly translate into improvements in patient care and outcome.

For example, if SMI is present and is not suspected, patients may undergo unnecessary endoscopic procedures for an LNPCP which will eventually require surgery anyway (inconvenience, delayed correct treatment). If the incorrect technique is performed in the context of superficial SMI, adequate assessment of complete excision or extent and type of SMI may not be possible and a patient who would otherwise have been cured may require surgery anyway (under-treatment, below standard of care outcome, delay to treatment). Conversely, if SMI is suspected in its absence patients may undergo unnecessary surgery, increased healthcare spends and mortality (over-treatment, unnecessary risk). If the presence of SMI could be accurately determined in real-time using endoscopic imaging, delays to treatment, over-treatment and the associated morbidity for patients could be avoided.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Endoscopists of varying abilities and grades (participant endoscopist) that consents electronically
  • Patients with LNPCPs who signed the ICF of UZ Ghent Hospital for the anonymous use images of their polyp taken during colonoscopy

排除标准

  • Endoscopist does not consent to inclusion (participant endoscopist)
  • Image of inadequate quality as per opinion of the principal investigator
  • Patient does not consent to data collection for the study (participant patient)

结局指标

主要结局

The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs.

时间窗: Through study completion, Study is open for 2 weeks

The accuracy of endoscopic assessment as to the risk of SMI within LNPCPs, using the Blink (first) impression when analysing images of LNPCPs.

次要结局

  • Identifying the parameters of LNPCPs that prompt endoscopist to have a positive Blink impression for the presence of SMI.(Through study completion, Study is open for 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验