White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Hp Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparative Study of White Light Endoscopy and Magnifying Endoscopy in Assessing the Status of Helicobacter Pylori Infection

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397066
• Other study ID #: 130028
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Jilin University
• Contact: Dong Yang, doctor
• Phone: 18844097668
• Email: 18844097668[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

1.Retrospectively 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 13/carbon-14 breath test result indicates a current Hp infection. If both of immunohistochemical or 13/carbon-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 (RAC)/irregular/disappearing, 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 NBI+ME 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, 25%

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Total gastric atrophy and endoscopic type A gastritis.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Procedure:
• White light endoscopy group
White light endoscopy observe the characteristics of mucosa under white light
• Magnifying endoscopy group
NBI+ME to observe the non atrophic area of the gastric fundus gland. The results depend on the ratio of gastric fundus gland.

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Chang chun	Ji Lin

Sponsors (1)

Lead Sponsor	Collaborator
Jilin University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of different observation method	white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection status)	at the end of the observation of endoscopy procedure
Secondary	Sensitivity of different observation method	white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection)	at the end of the observation of endoscopy procedure
Secondary	specificity of different observation method	white light endoscopy, magnifying endoscopy, and integrated endoscopic judgment to determine the status of Hp infection (including Hp current infection, Hp negative, and past H. pylori infection)	at the end of the observation of endoscopy procedure
Secondary	result of immunohistochemistry	Biopsy of Helicobacter pylori from the large and small curvature of the gastric antrum and the large and small curvature of the gastric body, and submission for immunohistochemical detection	the end of enrollment
Secondary	result of breath tests.	the results of carbon-13 or carbon-14 breath tests showed the Hp infection status	the end of enrollment