Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06324097
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-03-15
Brief Title:
Diagnostic Value of Endocytoscopy for Colorectal Lesions
Sponsor:
Hong Xu
Organization:
The First Hospital of Jilin University
Study Overview
Official Title:
Diagnostic Value of Two Different Mode Endocytoscopy for Colorectal Lesions
Status:
RECRUITING
Status Verified Date:
2024-04
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:
Colorectal cancer CRC is the third most common malignancy and the second leading cause of cancer-related death worldwide Colonoscopy is considered the preferred method of screening for colorectal cancer and resection of colorectal lesions can significantly reduce the incidence and mortality of colorectal cancer In order to improve the qualitative and quantitative diagnosis of colorectal lesions many endoscopic techniques such as image-enhanced endoscopy IEE including narrowband imaging NBI magnifying endoscopy pigment endoscopy confocal laser endoscopy and endocytoscopy EC are applied clinically The application of EC is intended to achieve the purpose of real-time histopathological endoscopic diagnosis without biopsy Several studies have shown that EC is effective in identifying the nature of colorectal lesions and judging the depth of invasion in CRC Based on the endoscopic diagnosis the endoscopist can determine the treatment plan for the colorectal lesions The latest EC is an integrated endoscope with a contact light microscopy system with a maximum magnification of 520 x EC may demonstrate the atypical of gland structure and cells after staining EC staining mode along with the use of the EC-NBI mode The endoscopic diagnosis of the EC staining mode is based on the EC classification EC-C used to predict the histopathological diagnosis of colorectal lesions A prospective randomized trial showed that the diagnostic accuracy was 941 by EC-C However the diagnostic value of EC-C depends on the operator and may be influenced by the quality of the staining Meanwhile the high-quality staining process is time-consuming and tedious Therefore EC-NBI seems to be the first choice for EC diagnosis with the advantages of convenient operation and efficient diagnosis EC-NBI can display the super-amplified surface microvessels of the lesion and provide pathological prediction according to the vessel classification EC-V EC-V achieved 99 diagnostic accuracy for hyperplastic polyps and 886 for invasive carcinoma In EC examination the investigators usually use EC-NBI and EC staining successively to diagnose colorectal lesions which is believed to improve the diagnostic performance However the diagnostic value of increasing EC-staining after EC-NBI examination for predicting the pathological nature of colorectal lesions is still unclear Therefore this retrospective study aimed to evaluate the diagnostic value of two different modalities of cell endoscopy for colorectal lesions and to clarify whether additional EC staining after EC-NBI could improve the diagnostic performance of predicting the pathological diagnosis of colorectal lesions
In the study the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis including EC-NBI and EC-staining and pathological diagnosis Then the investigators calculate the accuracy sensitivity specificity positive predictive value PPV negative predictive value NPV and high confidence diagnosis rate of EC-C and EC-V classification respectively Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated
In the study the investigators collect clinical information of colorectal lesions which were diagnosed by endoscopic diagnosis including EC-NBI and EC-staining and pathological diagnosis Then the investigators calculate the accuracy sensitivity specificity positive predictive value PPV negative predictive value NPV and high confidence diagnosis rate of EC-C and EC-V classification respectively Inter-and intra-observer agreement in the diagnosis of EC-C and EC-V will be calculated
Detailed Description:
None
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