Surrogate Quality Indicators for Adenoma Detection Rate (ADR)
NCT ID: NCT03919487
Last Updated: 2021-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
400 participants
OBSERVATIONAL
2018-07-01
2020-12-18
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adenoma Detection Rate of 3D Colonoscopy
NCT05153746
Examining Techniques on Adenoma Miss Rate in Proximal Colon
NCT03355443
Prospective Trial to Compare ADR of G-EYE™ Colonoscopy With Standard Colonoscopy
NCT02545699
Impact of SE of the Proximal Colon on the AMR
NCT05712304
Adenoma Detection Rate Using AI System in China
NCT03840590
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
However, a Polish study reported a 10-fold higher risk of intermediate cancer when ADR was below 20%, and a recent large study by Corley showed that the incidence of colorectal cancer could be reduced by 3% and the mortality rate of colorectal cancer by 5% or more, especially when the ADR is increased by 1%.
Based on the evidence that the higher the ADR and the lower the risk of colorectal cancer, the quality index of colonoscopy was revised in 2015. Currently, the recommended ADR is 30% for men and 20% for women.
Although ADR appears to be a perfect quality marker, it requires a diagnosis of adenoma of the pathologic outcome in order to obtain ADR.
In particular, the calculation of ADR is based on the assumption that more than one adenoma is diagnosed during colonoscopy. However, even if the number of adenomas diagnosed during colonoscopy is different for each endoscopist, the concept of ADR does not distinguish this difference.
In fact, many recent studies have reported that endoscopist with an ADR more than 40% showed more than 20% adenoma missing rate.
The recent proposed measures to replace ADR include polyp detection rate (PDR) and adenoma per colonoscopy rate (APC). As with ADR, PDR is a measure of the rate at which more than one colorectal polyps are found in a colonoscopy practitioner aged 50 years or older. Unlike ADR, PDR does not need pathologic result. Recently, several studies have been reported that PDR can replace ADR and can be correlated with colorectal cancer prevention. The APC is different from that of ADR, and it is considered to be one of the alternative indicators that can compensate the shortcomings of "one and done" concept of ADR, because it can reflect the number of all adenomas found in the entire colon. According to a single-institution study using more than 20,000 colonoscopy analyzes that the recommended values for ADR 20% for men and women with ADR 15% for men over 50 years of age were APC 0.3.
In addition to APC, Adenoma per positive participants (APP), the total number of adenomas of participants divided by the number of examinees of adenomas detected (positive APPs), and the number of ADR-plus (ADR-plus) in the average number of additional found adenomas per test case divided by total colonoscopy were also introduced as quality indicators to predict the overlook of the lesion substitute for ADR.
In this regard, various substitute factors such as PDR, APC, and recently reported APP and ADR-plus have been introduced as an index parameter that can be used as a quality index to reflect the neglect of adenomas during colonoscopy. However, there is a very limited study of the direct comparison of correlation between each quality indicators and adenoma miss rate (AMR), and also the investigators have very limited knowledge which quaility incidator can well reflect the AMR.
The aim of this study was to investigate the efficacy of quality indicators which could best reflect the AMR and to find surrogate markers of ADR.
The primary endpoint of this study is to evaluate the relationship between known quality markers such as ADR, PDR, APC, APP, ADR-Plus, and AMR is examined.
This study will be performed as a cross-sectional study with prospective design.
Total of eight expert colonoscopists will participate in this study, and collecting the 50 colonoscopy data in each endoscopist. All enrolled cases will be subject for screening colonoscopy aged 50-75 years old.
This study excluded the colonoscopy cases with inappropriate bowel preparation, inflammatory bowel disease patients, and high-risk patients with family history of hereditary colorectal cancer.
Colon cleansing will be performed by the split method. Colonoscopy is performed by back-to-back two colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. Only small polyps less than 5 mm located in the S-colon and rectum are left after photographing.
After performing the first colonoscopy, the second colonoscopy is performed immediately. A newly founded polyp (except polypoid and S-colon and rectal polyp which was left as a photograph at the time of 1st colonoscopy when performing a second colonoscopy) will be considered as a missed lesion and will be removed. After the procedure, confirm the presence of adenomatous polyps by pathologic results and record them on the case record. 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. The correlations between ADR, PDR, APC, ADR-plus, APP, and AMR are compared using Pearson correlation constants.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Back-to-back colonoscopy group
As I described the study method in the protocol, the experimental group will be a screening colonoscopy cohort with back to back method. In fact, this study is to evaluate the correlation between quality indicators of colonoscopy and adenoma miss rate (AMR), and intervention is a single arm for back-to-back colonoscopy.
Back to back colonoscopy
After first colonoscopy performing with polypectomy, the 2nd colonoscopy will be performed right after the 1st colonoscopy, and if the missed lesion during the 1st colonoscopy will be found, it should be removed.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Back to back colonoscopy
After first colonoscopy performing with polypectomy, the 2nd colonoscopy will be performed right after the 1st colonoscopy, and if the missed lesion during the 1st colonoscopy will be found, it should be removed.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Inflammatory bowel disease patients
3. 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)
4. History of colorectal cancer or colon surgery
5. If the insertion of the appendix fails
6. A patient who does not agree with sleep induction calming
50 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Soonchunhyang University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hyun Gun, Kim. M.D., Ph.D.
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hyun Gun Kim, Professor
Role: STUDY_DIRECTOR
Soonchunhyang University College of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Soonchunhyang univerisity hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CORE study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.