Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397066
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-04-30
Brief Title:
White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Hp Infection
Sponsor:
Jilin University
Organization:
Jilin University
Study Overview
Official Title:
Comparative Study of White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Helicobacter Pylori Infection
Status:
RECRUITING
Status Verified Date:
2024-05
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:
By comparing the characteristics of Helicobacter pylori Hp infection under magnifying endoscopy and white light endoscopy and making judgments of Hp infection status the advantages and disadvantages of the two endoscopic examination methods are summarized to improve the accuracy of subsequent endoscopic Hp infection status judgments
Detailed Description:
This study adopts a cross-sectional study The expected recruitment time for all participants is 12 months Our endoscopy center conducts magnifying staining endoscopy examination along with endoscopic Hp immunohistochemical testing and cases that have recently completed carbon-13 or carbon-14 breath tests
1Retrospectively enrolled cases from August 1 2022 to April 30 2024 who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University All enrolled cases had carbon-13 or carbon-14 breath tests excluding cases of total gastric atrophy and endoscopic type A gastritis The criteria for determining the status of Hp infection A positive immunohistochemical or 13carbon-14 breath test result indicates a current Hp infection If both of immunohistochemical or 13carbon-14 breath test result are negative combined with the treatment history for Hp infection and endoscopic manifestations they are further classified as non-infection or past H pylori infection If there is a treatment history for Hp infection or obvious atrophy under the endoscopy in which atrophy degree greater than or equal to Kimura-Takemoto classification C2 atrophy exceeding the gastric angle it is considered as past H pylori infection If there is no such manifestation it is considered Hp non-infection Extract the relevant characteristics of Hp infection under white light and magnifying endoscopy from continuous inclusion of cases and determine the Hp infection status separately The characteristics of white light endoscopic extraction include degree of atrophy Kimura-Takemoto classification congestion and edema yellow white nodules mucus turbidity the arrangement of the collecting veins is regular RACirregulardisappearing goose flesh map-like redness blood scabs gastric fundus gland polyps and scratch syndrome and are judged according to the Kyoto Classification of Gastritis Magnifying endoscopy uses NBIME to observe the non atrophic area of the gastric fundus gland According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view it is classified as grade 1 25 indicating Hp current infection 25grade 250 Hp uncertain state indicating Hp current infection or after recent sterilization grade 3 50 indicating Hp non-infection or past H pylori infection The investigators conduct a comparative study between white light endoscopy and magnifying endoscopy and conduct subgroup analysis based on Hp infection status
Based on the characteristics of white light endoscopy and magnifying endoscopy summarize and sort out the integrated endoscopic Hp infection status judgment process named the integrated endoscopic judgment
Prospective enrollment From May 1 2024 to December 31 2024 patients who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University All enrolled cases had carbon-13 or carbon-14 breath tests excluding cases of total gastric atrophy and endoscopic type A gastritis Using the white light endoscopy magnifying endoscopy and integrated endoscopic judgment to determine the Hp infection status three different endoscopic Hp judgment results will be obtained and data comparison conducted between the three groups
All enrolled cases were evaluated blindly by two doctors If there was no consensus the third doctor would further evaluate and determine the Hp infection status under white light endoscopy magnifying endoscopy and integrated endoscopic judgment Based on the comparison results a more accurate endoscopic method will be selected to determine the Hp infection status
1Retrospectively enrolled cases from August 1 2022 to April 30 2024 who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University All enrolled cases had carbon-13 or carbon-14 breath tests excluding cases of total gastric atrophy and endoscopic type A gastritis The criteria for determining the status of Hp infection A positive immunohistochemical or 13carbon-14 breath test result indicates a current Hp infection If both of immunohistochemical or 13carbon-14 breath test result are negative combined with the treatment history for Hp infection and endoscopic manifestations they are further classified as non-infection or past H pylori infection If there is a treatment history for Hp infection or obvious atrophy under the endoscopy in which atrophy degree greater than or equal to Kimura-Takemoto classification C2 atrophy exceeding the gastric angle it is considered as past H pylori infection If there is no such manifestation it is considered Hp non-infection Extract the relevant characteristics of Hp infection under white light and magnifying endoscopy from continuous inclusion of cases and determine the Hp infection status separately The characteristics of white light endoscopic extraction include degree of atrophy Kimura-Takemoto classification congestion and edema yellow white nodules mucus turbidity the arrangement of the collecting veins is regular RACirregulardisappearing goose flesh map-like redness blood scabs gastric fundus gland polyps and scratch syndrome and are judged according to the Kyoto Classification of Gastritis Magnifying endoscopy uses NBIME to observe the non atrophic area of the gastric fundus gland According to the proportion of the opening of the gastric fundus gland duct in one magnified field of view it is classified as grade 1 25 indicating Hp current infection 25grade 250 Hp uncertain state indicating Hp current infection or after recent sterilization grade 3 50 indicating Hp non-infection or past H pylori infection The investigators conduct a comparative study between white light endoscopy and magnifying endoscopy and conduct subgroup analysis based on Hp infection status
Based on the characteristics of white light endoscopy and magnifying endoscopy summarize and sort out the integrated endoscopic Hp infection status judgment process named the integrated endoscopic judgment
Prospective enrollment From May 1 2024 to December 31 2024 patients who underwent magnifying endoscopic examination with endoscopic Hp immunohistochemical testing result at the Endoscopy Center of the First Hospital of Jilin University All enrolled cases had carbon-13 or carbon-14 breath tests excluding cases of total gastric atrophy and endoscopic type A gastritis Using the white light endoscopy magnifying endoscopy and integrated endoscopic judgment to determine the Hp infection status three different endoscopic Hp judgment results will be obtained and data comparison conducted between the three groups
All enrolled cases were evaluated blindly by two doctors If there was no consensus the third doctor would further evaluate and determine the Hp infection status under white light endoscopy magnifying endoscopy and integrated endoscopic judgment Based on the comparison results a more accurate endoscopic method will be selected to determine the Hp infection status
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