Ignite Creation Date:
2024-05-06 @ 1:22 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT04000243
Status:
COMPLETED
Last Update Posted:
2023-03-01
First Post:
2019-06-21
Brief Title:
Diagnosis of Helicobacter Pylori Based on Gastric Collecting Venules
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
Interobserver Agreement of Endoscopic Diagnosis of Helicobacter Pylori Based on the Arrangement of Gastric Collecting Venules Prospective and Multicenter Study
Status:
COMPLETED
Status Verified Date:
2023-02
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:
Helicobacter pylori Hp is the major cause of gastritis and gastritis-associated diseases Detection of a regular arrangement of collecting venules RAC pattern in the lesser gastric curvature correlates with negative Hp status with a sensitivity and negative predictive value NPV higher than 90 in Asian countries
In a recent study carried out in our hospital it has been shown that the presence of RAC pattern in the lesser gastric curvature evaluated with high definition endoscopy can accurately identify patients without Hp
The aim of this study is to confirm the validity of the endoscopic diagnosis of Hp infection in the West by means of the RAC pattern in a multicenter prospective study and to evaluate interobserver variability before establishing its applicability in clinical practice
In a recent study carried out in our hospital it has been shown that the presence of RAC pattern in the lesser gastric curvature evaluated with high definition endoscopy can accurately identify patients without Hp
The aim of this study is to confirm the validity of the endoscopic diagnosis of Hp infection in the West by means of the RAC pattern in a multicenter prospective study and to evaluate interobserver variability before establishing its applicability in clinical practice
Detailed Description:
We designed a prospective study including patients who will undergo upper gastrointestinal endoscopy from July 2019 to June 2020 at the Endoscopy Unit of Hospital Clinic of Barcelona
The Ethics Committee of Hospital Clinic of Barcelona approved the study
Upper gastrointestinal endoscopies will be performed with high definition endoscopes Olympus Germany without magnification by three endoscopists One of the endoscopists is considered as an expert with more than 20 years of experience and prior training in Japanese centers All the examinations will be performed with sedation controlled by an anesthesiologist After the routine examination of the esophagus stomach and duodenum close observation will be carried out at the distal part of the lesser curvature and pictures will be taken The Olympus system will be used for image storing and text reporting
The presence of a regular or irregular arrangement of collecting venules will be evaluated in real time during gastric exploration in the lower part of the lesser curvature of the gastric body with good insufflation close to the incisura angularis If minute red points were visible regularly and homogenously the finding will be scored as RAC positive RAC If this finding was absent or there was a patchy distribution at the site of close observation it will be defined as RAC negative RAC-
The following baseline characteristics will be collected age sex antibiotics proton-pump inhibitors non-steroidal anti-inflammatory drugs NSAIDs antithrombotic or anticoagulant use in the last two weeks history of Hp eradication and detection of significant endoscopic findings erosive duodenitis non-erosive duodenitis duodenal ulcer erosive gastritis gastric ulcer and signs of atrophic gastritis or intestinal metaplasia
Hp infection status will be determined by mucosal biopsies We will perform 5 samples for histological study according to Sydney criteria 2 in antrum 1 in incisura angularis and 2 in gastric body or 2 biopsies 1 in antrum and 1 in gastric body for histology and immunohistochemical study for Hp Patients were classified as Hp positive if one of these two tests are positive
For the histological study samples will be fixed in formalin and stained with hematoxylin and eosin for the evaluation of gastritis and with Giemsa for Hp status The immunohistochemical study will be carried out systematically in the case of a negative histological study for Hp The pathologist has access to the endoscopic diagnosis but not to RAC status
Statistical analysis
The quantitative variables will be described by the mean and the standard deviation while the qualitative variables by proportion The sensitivity specificity positive predictive value PPV NPV and accuracy of RAC for the diagnosis of uninfected Hp patients will be calculated 95 confidence interval will be calculated by using standard formula Comparisons will be done using Chi-square test for categorical variables and t test for continuous variables In addition a multivariate logistic regression analysis will be carried out to assess the existence of predictive factors of RAC and the odds ratio OR was calculated to indicate the associated risk P 0 05 will be considered statistically significant All statistical analyses will be performed using the SPSS version 23 SPSS Inc Chicago USA
The Ethics Committee of Hospital Clinic of Barcelona approved the study
Upper gastrointestinal endoscopies will be performed with high definition endoscopes Olympus Germany without magnification by three endoscopists One of the endoscopists is considered as an expert with more than 20 years of experience and prior training in Japanese centers All the examinations will be performed with sedation controlled by an anesthesiologist After the routine examination of the esophagus stomach and duodenum close observation will be carried out at the distal part of the lesser curvature and pictures will be taken The Olympus system will be used for image storing and text reporting
The presence of a regular or irregular arrangement of collecting venules will be evaluated in real time during gastric exploration in the lower part of the lesser curvature of the gastric body with good insufflation close to the incisura angularis If minute red points were visible regularly and homogenously the finding will be scored as RAC positive RAC If this finding was absent or there was a patchy distribution at the site of close observation it will be defined as RAC negative RAC-
The following baseline characteristics will be collected age sex antibiotics proton-pump inhibitors non-steroidal anti-inflammatory drugs NSAIDs antithrombotic or anticoagulant use in the last two weeks history of Hp eradication and detection of significant endoscopic findings erosive duodenitis non-erosive duodenitis duodenal ulcer erosive gastritis gastric ulcer and signs of atrophic gastritis or intestinal metaplasia
Hp infection status will be determined by mucosal biopsies We will perform 5 samples for histological study according to Sydney criteria 2 in antrum 1 in incisura angularis and 2 in gastric body or 2 biopsies 1 in antrum and 1 in gastric body for histology and immunohistochemical study for Hp Patients were classified as Hp positive if one of these two tests are positive
For the histological study samples will be fixed in formalin and stained with hematoxylin and eosin for the evaluation of gastritis and with Giemsa for Hp status The immunohistochemical study will be carried out systematically in the case of a negative histological study for Hp The pathologist has access to the endoscopic diagnosis but not to RAC status
Statistical analysis
The quantitative variables will be described by the mean and the standard deviation while the qualitative variables by proportion The sensitivity specificity positive predictive value PPV NPV and accuracy of RAC for the diagnosis of uninfected Hp patients will be calculated 95 confidence interval will be calculated by using standard formula Comparisons will be done using Chi-square test for categorical variables and t test for continuous variables In addition a multivariate logistic regression analysis will be carried out to assess the existence of predictive factors of RAC and the odds ratio OR was calculated to indicate the associated risk P 0 05 will be considered statistically significant All statistical analyses will be performed using the SPSS version 23 SPSS Inc Chicago USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None