JPRN-jRCTs072180006已完成3 期
Evaluation of availability of linked color imaging compared to white light imaging colonoscopy for detection of colonic adenomas: a multicenter prospective study - LCI-detection study
Shimoda Ryo0 个研究点目标入组 678 人开始时间: 2018年11月12日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 678
研究概览
简要总结
A multicenter, randomized, back-to-back design study was conducted to compare LCI and WLI on the detection of colonic adenomas. The primary endpoint was the miss rate. The full analysis set was 327 and 320 in LCI-WLI group and WLI-LCI group, respectively. The mean miss rates were 9.3% and 20.6% in LCI-WLI group and WLI-LCI group, respectively, and it was statistically significant (Wilcoxon test, P<0.001). It was concluded that LCI was superior to WLI on detection of colonic adenomas.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 79age old（—）
- 性别
- All
入选标准
- •1) Lower GI endoscopy examinee who are between 18 and 79 years (at the time signing informed consent)
- •2) Patients who understand the contents of informed consent form and who can voluntarily sign informed consent form (in the case of a minor, also informed consent from proxies)
- •3) Patients who does not receive lower digestive tract endoscopy in the institute concerned for the past three years
- •4) Patients requiring lower digestive tract endoscopy (meeting any of the following criteria)
- •(a)Positive fecal occult blood
- •(b)Subjects with diagnosis or treatment history of large intestine adenoma, colorectal cancer (it is ineligible if colon/rectum resection was undertaken)
- •(c)Subjects with digestive symptoms such as abdominal pain, diarrhea and constipation
- •(d)Subjects who requires the screening of gastrointestinal cancer
- •(e)Subjects with a family affection history of colorectal cancer and large intestine adenoma
- •(f)Any other subjects who are regarded that the investigator needed lower digestive tract endoscopy
排除标准
- •1)Patients who have undergone intestinal resection
- •2)Patients with a history of inflammatory bowel disease
- •3)Patients with a history of familial adenomatous polyposis
- •4)Patients with a history of hereditary nonpolyposis colorectal cancer
- •5)Patients with severe intestinal adhesions known beforehand
- •6)Patients who the investigator determined difficult to participate in the study
研究者
相似试验
Unknown
不适用
AI for Colorectal Polyp Detection in EndoscopyFocus of the Study is to Evaluate a New Developed Deep-learning Computer-aided Detection System in Combination With LCI for Colorectal Polyp DetectionNCT04339855Johannes Gutenberg University Mainz600
Unknown
不适用
Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative ColitisUlcerative ColitisNCT02772406Affiliated Hospital to Academy of Military Medical Sciences60
已完成
不适用
Linked Color Imaging Versus Narrow Band Imaging for Colorectal Adenoma DetectionColon AdenomaNCT03336359The University of Hong Kong272
已完成
不适用
Linked Color Imaging Versus High-definition White Light Endoscopy for the Detection of Polyps in Patients With Lynch Syndrome (LCI-LYNCH)Lynch SyndromeColonoscopyNCT03344289Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)357
Enrolling By Invitation
2 期
Impact of Linked color imaging (LCI) on the learning curve and quality in colonoscopy of naïve gastroenterology traineesTo compare the difference in sensitivity between LCI and WL endoscopy for the detection of colorectal polyps by naive gastroenterology traineeLCIWLIColorectal polyps detectionAdenoma detection rate(ADR)Small adenoma detection rateAdenoma per colonoscopyPolyp per colonoscopyACE tool scoreLearning curve of adenoma and polyp deTCTR20190927002Gastroenterological association of Thailand2,076