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临床试验/NCT03506321
NCT03506321已完成不适用

Comparative Analysis of the Incremental Benefit of Chromoendoscopy in Addition to High Definition White Light (HD-WL)and Narrow Band Imaging (NBI) for the Prediction of Submucosal Invasive Cancer Within Laterally Spreading Lesions (LSLs) and in Determining the Presence of Residual or Recurrent Adenoma at a Post Endoscopic Resection Scar

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年2月7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
400
试验地点
1
主要终点
Compare chromoendoscopy predictions and HD-WL/NBI predictions of submucosal invasive cancer (SMIC) and residual or recurrent adenoma (RRA) to compare correlation with histological findings

研究概览

简要总结

To compare the incremental benefit of chromoendoscopy in addition to high definition white light and narrow band imaging in predicting submucosal invasion within laterally spreading lesions in the colon and in determining the presence of residual or recurrent adenoma at the post endoscopic resection scar

详细描述

Wide-field (WF) EMR is now accepted as a safe and effective alternative to surgery for removal of large (>20mm) laterally spreading lesions (LSLs).

Assessment of the risk of submucosal invasive cancer (SMIC) is paramount to determining whether a lesion should be attempted for resection by endoscopic mucosal resection (EMR). Lesions that are at high risk for invading the submucosa should either be referred for surgery or in selected cases may be removed by endoscopic submucosal dissection (ESD) in an en bloc fashion to assess SMIC accurately. Tools to assess the likelihood of SMIC endoscopically include analysis of the Kudo pit-pattern (KPP) combined with assessment of morphology as per Paris classification.

KPP analysis is useful to predict histology based on the microarchitecture of pits, epithelial crests or ridges. It thus provides an assessment of risk of sub-mucosal invasion of superficial lesions. There are five categories; with Type 1 and 2 being non-tumours i.e. benign lesion, as compared to Type 3-5 which are tumours ranging from pre-cancerous adenomas (tubular or villous adenoma) to invasive cancer.

Assessment of lesion morphology at WF-EMR using the Paris Classification and analysis of the surface pit-pattern are an integral part of identifying lesions suitable for EMR.

As per the Paris Classification superficial lesions in the colon are divided into; polypoid, non-polypoid and mixed types. Non-polypoid lesions are further divided into slightly raised (0-IIa), flat (0-IIb), depressed surface (0-IIc) or mixed types such as a flat lesion with a nodule (0-IIa+b). The later generally have a greater risk for sub-mucosal invasion (SMI) than polypoid lesions and can be as high as 35-40%. Flat lesions are referred to as laterally spreading lesions (LSLs) if greater than 10mm. There are two distinct subtypes; non-granular vs granular. Granular LSLs exhibit a lower risk of SMI as compared to non-granular LSLs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • •Patients able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent
  • •Patients referred to Westmead and Auburn Hospital Endoscopy Unit for a colonoscopy for all indications

排除标准

  • •Patient's with known colonic strictures/stenosis
  • •Patient's with active inflammatory bowel disease
  • •Pregnancy
  • •Patients who did not consent to study

研究组 & 干预措施

LANS

Other

Lesions are assessed with chromoendoscopy, HD-WL & NBI

干预措施: chromoendoscopy, high definition white light and narrow band imaging (Diagnostic Test)

结局指标

主要结局

Compare chromoendoscopy predictions and HD-WL/NBI predictions of submucosal invasive cancer (SMIC) and residual or recurrent adenoma (RRA) to compare correlation with histological findings

时间窗: Three years

次要结局

  • Compare inter-observer agreement of presence of SMIC using high definition imaging and chromoendoscopy(Three years)
  • Accurate histologic correlation as predicted by Kudo pit pattern classification(Three years)
  • Compare the difference between live endoscopic assessment and use of carefully selected endoscopic images to predict SMIC(Three years)

研究者

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

Professor Michael Bourke

Director of Gastrointestinal Endoscopy

Western Sydney Local Health District

研究点 (1)

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