Ignite Creation Date:
2024-05-06 @ 1:02 PM
Last Modification Date:
2024-10-26 @ 1:08 PM
Study NCT ID:
NCT03919487
Status:
COMPLETED
Last Update Posted:
2021-03-10
First Post:
2019-03-07
Brief Title:
Surrogate Quality Indicators for Adenoma Detection Rate ADR
Sponsor:
Soonchunhyang University Hospital
Organization:
Soonchunhyang University Hospital
Study Overview
Official Title:
Correlation Between Surrogate Quality Indicators for Adenoma Detection Rate ADR and Adenoma Miss Rate AMR in Qualified Colonoscopy CORE Study
Status:
COMPLETED
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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 37 In the case of proximal colon the incidence of intermediate cancer was 24 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
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 20000 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 03
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
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 20000 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 03
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None