Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06173297
Status:
COMPLETED
Last Update Posted:
2023-12-15
First Post:
2023-12-04
Brief Title:
Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions
Sponsor:
Hospital Sirio-Libanes
Organization:
Hospital Sirio-Libanes
Study Overview
Official Title:
Assessing the Agreement Between Endoscopic and Histopathological Diagnosis of Colorectal Sessile Serrated Lesions
Status:
COMPLETED
Status Verified Date:
2023-12
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:
The goal of this observational study was to assess the degree of agreement between the endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions in adult patients undergoing colonoscopy in Hospital Sírio-Libanes
The main questions it aimed to answer were
The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement
To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês
To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method
To assess the accuracy positive predictive value and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis
The data were prospectively collected through a form specifically designed for this project that was completed immediately after the examination by the performing colonoscopist All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy
The main questions it aimed to answer were
The degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions by calculating the Kappa Value of agreement
To establish the detection rate of sessile serrated lesions and adenomas in the Endoscopy Department at Hospital Sírio-Libanês
To evaluate the degree of agreement between endoscopic and anatomopathological diagnosis of sessile serrated colorectal lesions based on the resection method
To assess the accuracy positive predictive value and negative predictive value of endoscopic diagnosis of serrated lesions compared to anatomopathological diagnosis
The data were prospectively collected through a form specifically designed for this project that was completed immediately after the examination by the performing colonoscopist All patients enrolled in this study agreed to participate in it and signed an informed consent form prior to the colonoscopy
Detailed Description:
The study population was
Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit São Paulo Brazil between June and August 2020
The sample
For the present study an odds ratio of 15 in the adenoma detection rate of colorectal lesions was considered concerning the vascular pattern classification of the lesion NICE with an expected discordance rate of 30 regarding the histopathological pattern To achieve this an estimated sample size of 758 patients was calculated considering an 80 statistical power and a risk α5 for a Type I error using the McNemars test for proportions
Inclusion criteria
Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020
Age over 18 years
Exclusion criteria
Patients with inflammatory bowel disease IBD
Patients diagnosed with hereditary polyposis or non-polyposis syndromes
Patients with a history of colorectal surgery
Patients previously diagnosed with colorectal cancer CRC
Study variables analyzed
Age years
Gender
Colon preparation Boston Scale
Presence of colorectal lesions
Lesion resection technique
Lesion size
Lesion location
Morphological classification of the lesion Paris
Vascular pattern classification of the lesion NICE
Number of lesions found per examinationpatient
Methods
All colonoscopies in this study were conducted in the endoscopy department of Hospital Sírio-Libanês and the equipment used was the Olympus EVIS Exera III - CV190
All lesions identified in the study were sent to the pathology service of Hospital Sírio-Libanês for specialized and standardized anatomopathological analysis The pathologists were blinded to the endoscopic diagnosis of the lesions The lesions were classified according to the 2019 WHO Classification and subsequently categorized for this study into hyperplastic polyps adenomas sessile serrated lesions adenocarcinoma or others
Statistical analysis
Data obtained was assessed using the Gaussian curve and determined as parametric or non-parametric using the Kolmogorov-Smirnov test and the Shapiro-Wilk test Parametric data were represented by mean and standard deviation while non-parametric data were represented by median and interquartile range 25th and 75th percentiles Categorical data were represented by absolute frequency n and relative frequency and presented through contingency tables
Sensitivity specificity positive predictive values and negative predictive values with corresponding 95 confidence intervals of colonoscopy for diagnosing sessile serrated lesions using the anatomopathological examination as the gold standard were calculated
To evaluate agreement between colonoscopy diagnosis and anatomopathological diagnosis both overall and according to the resection method employed Cohens Kappa coefficients and their respective 95 confidence intervals were calculated These coefficients were then categorized based on Landis Kochs criteria 1977
Ethical considerations
The research project for this study was thoroughly detailed and submitted for analysis to the Research Ethics Committee CEP of Hospital Sírio-Libanês receiving approval under CAAE 27604919200005461 Patients participating in the study agreed to take part and signed the Informed Consent Form The involved colonoscopists committed to maintaining the confidentiality of the data
Patients aged over 18 undergoing colonoscopy at Hospital Sírio-Libanês in the Bela-Vista unit São Paulo Brazil between June and August 2020
The sample
For the present study an odds ratio of 15 in the adenoma detection rate of colorectal lesions was considered concerning the vascular pattern classification of the lesion NICE with an expected discordance rate of 30 regarding the histopathological pattern To achieve this an estimated sample size of 758 patients was calculated considering an 80 statistical power and a risk α5 for a Type I error using the McNemars test for proportions
Inclusion criteria
Patients undergoing elective colonoscopy at Hospital Sírio-Libanês between February 2020 and August 2020
Age over 18 years
Exclusion criteria
Patients with inflammatory bowel disease IBD
Patients diagnosed with hereditary polyposis or non-polyposis syndromes
Patients with a history of colorectal surgery
Patients previously diagnosed with colorectal cancer CRC
Study variables analyzed
Age years
Gender
Colon preparation Boston Scale
Presence of colorectal lesions
Lesion resection technique
Lesion size
Lesion location
Morphological classification of the lesion Paris
Vascular pattern classification of the lesion NICE
Number of lesions found per examinationpatient
Methods
All colonoscopies in this study were conducted in the endoscopy department of Hospital Sírio-Libanês and the equipment used was the Olympus EVIS Exera III - CV190
All lesions identified in the study were sent to the pathology service of Hospital Sírio-Libanês for specialized and standardized anatomopathological analysis The pathologists were blinded to the endoscopic diagnosis of the lesions The lesions were classified according to the 2019 WHO Classification and subsequently categorized for this study into hyperplastic polyps adenomas sessile serrated lesions adenocarcinoma or others
Statistical analysis
Data obtained was assessed using the Gaussian curve and determined as parametric or non-parametric using the Kolmogorov-Smirnov test and the Shapiro-Wilk test Parametric data were represented by mean and standard deviation while non-parametric data were represented by median and interquartile range 25th and 75th percentiles Categorical data were represented by absolute frequency n and relative frequency and presented through contingency tables
Sensitivity specificity positive predictive values and negative predictive values with corresponding 95 confidence intervals of colonoscopy for diagnosing sessile serrated lesions using the anatomopathological examination as the gold standard were calculated
To evaluate agreement between colonoscopy diagnosis and anatomopathological diagnosis both overall and according to the resection method employed Cohens Kappa coefficients and their respective 95 confidence intervals were calculated These coefficients were then categorized based on Landis Kochs criteria 1977
Ethical considerations
The research project for this study was thoroughly detailed and submitted for analysis to the Research Ethics Committee CEP of Hospital Sírio-Libanês receiving approval under CAAE 27604919200005461 Patients participating in the study agreed to take part and signed the Informed Consent Form The involved colonoscopists committed to maintaining the confidentiality of the data
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