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

NCT06397066 | Recruiting DMC

• 1 other identifier: 130028
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Hp infection status; magnifying endoscopy; white light endoscopy; immunohistochemical test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Sensitivity of different observation method

  at the end of the observation of endoscopy procedure

• specificity of different observation method

  at the end of the observation of endoscopy procedure

• result of immunohistochemistry

  the end of enrollment

• result of breath tests.

  the end of enrollment

Study Arms (2)

the white light endoscopy group

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.

Procedure: White light endoscopy group

the Magnifying endoscopy group

Magnifying endoscopy(ME) uses Narrow Band Imaging (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%\<grade 2\<50%, Hp uncertain state, indicating Hp current infection or after recent sterilization, grade 3 ≥ 50%, indicating Hp non-infection or past H. pylori infection.

Procedure: Magnifying endoscopy group

Interventions

White light endoscopy group PROCEDURE

White light endoscopy observe the characteristics of mucosa under white light

the white light endoscopy group

Magnifying endoscopy group PROCEDURE

NBI+ME to observe the non atrophic area of the gastric fundus gland. The results depend on the ratio of gastric fundus gland.

the Magnifying endoscopy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• \- 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.

You may not qualify if:

• \- Total gastric atrophy and endoscopic type A gastritis.

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

RECRUITING

Study Officials

• Dong Yang, doctor

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Yang, doctor

CONTACT

18844097668; 18844097668@163.com

Dong Yang, doctor

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisted Investigator

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 2, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)