Correlation Between Surrogate Quality Indicators for Adenoma Detection Rate (ADR) and Adenoma Miss Rate (AMR) in Qualified Colonoscopy: CORE Study
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
- Correlation between adenoma missing rate during the colonoscopy and other colonoscopy quality indicators in each endoscopist.
研究概览
简要总结
This study is to evaluate the correlation of adenoma missing rate and quality indicators of colonoscopy including adenoma detection ratee (ADR), polyp detection rate (PDR), adenoma per colonoscopy rate (APC), adenoma per positive participant (APP), ADR-Plus, and to find out the surrogate indicators of ADR. This study is a prospective observational multi-center study. Correlation between AMR and quality indicators of colonoscopy based on the previous studies, 8 endoscopists participated in this study and will enroll 50 screening colonoscopies respectively.
Recruit research participants who want to participate in research in outpatient clinics. Perform colonoscopy in the morning after colon cleansing with split method. Colonoscopy is performed by back-to-back two consecutive colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. After retracting to the anus of the first colonoscopy, the second colonoscopy is performed immediately. In case of newly detected colon polyps except for the small polyps and S-colon and rectal polyps which were left as photographs during the first colonoscopy with the second colonoscopy, we regard them as an overlooked lesion during the first colonoscopy. After the procedure, the histologic examination is confirmed and classified as benign lesions (all adenomas, advanced adenomas, dysplasia, and colorectal cancer) and non-lesion lesions.
Using the back-to-back colonoscopy results of the participants during the study period, calculate the quality indicators including ADR, PDR, APC, ADR-plus, APP and AMR for each endoscopist. And then, evaluate the correlation between AMR and other quality indicators.
详细描述
Background Colonoscopy reduces the risk of colorectal cancer by 77% and reduces mortality from colorectal cancer by more than 30%. However, in spite of the advantages of colonoscopy, the meta-analysis reported an incidence of intermediate cancer of 3.7%. In the case of proximal colon, the incidence of intermediate cancer was 2.4 times higher than that of the distal colon.
There are several possible causes of intermediate cancers, such as missed lesion during the previous colonoscopy, early-growth tumors before the follow-up period, and incomplete resection of the lesions. About 70-80% intermediate cancers are known to be originated from an missed lesion on endoscopy, and 10 ~ 27% is known to be caused by incomplete resection of the lesion on the previous colonoscopy.
The quality of colonoscopy for the prevention of intermediate cancer was first reported by the American Society of Gastrointestinal Endoscopy (ASGE) / American College of Gastroenterology (ACG) Task Force on Quality in Endoscopy in 2006 and the recently revised Quality indicators for colonoscopy (Quality index of colonoscopy) '.
The most popular and practically being used quality indicator of colonoscopy is an adenoma detection rate (ADR).
ADR is calculated as the number of colonoscopy with ≥1 adenoma detected during the colonoscopy divided by the total number of colonoscopies. ACGTF recommended the criteria of the quality index of the colonoscopy prior to the revision ADR was defined as 25% or more for men and 15% or more for women.
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
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •A 50-to 75-year-old colon cancer screening colonoscopist who has had previous colonoscopy experience or has had a colonoscopy within the last 5 years
排除标准
- •Total bowel preparation deficient (total bowel preparation by Boston bowel preparation scale <6 or any region score <2)
- •Inflammatory bowel disease patients
- •Family history of hereditary colorectal cancer (family history of two or more colorectal cancer or family history of at least one cancer diagnosed before age 60)
- •History of colorectal cancer or colon surgery
- •If the insertion of the appendix fails
- •A patient who does not agree with sleep induction calming
结局指标
主要结局
Correlation between adenoma missing rate during the colonoscopy and other colonoscopy quality indicators in each endoscopist.
时间窗: Within 1 year
colonoscopy quality indicators including adenoma detection rate, polyp detection rate, adenoma per colonoscopy, adenoma detection rate-plus, adenoma per positive participant
次要结局
- Evaluation of surrogate indicators of ADR(Within 1 year)
研究者
Hyun Gun, Kim. M.D., Ph.D.
Professor
Soonchunhyang University Hospital