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临床试验/NCT06397066
NCT06397066已完成不适用

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

Jilin University1 个研究点 分布在 1 个国家目标入组 384 人开始时间: 2024年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
384
试验地点
1
主要终点
Accuracy of different observation method

研究概览

简要总结

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.

详细描述

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%<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. 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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •- 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: White light endoscopy group (Procedure)

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.

干预措施: Magnifying endoscopy group (Procedure)

结局指标

主要结局

Accuracy of different observation method

时间窗: at the end of the observation of endoscopy procedure

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)

次要结局

  • result of immunohistochemistry(the end of enrollment)
  • specificity of different observation method(at the end of the observation of endoscopy procedure)
  • Sensitivity of different observation method(at the end of the observation of endoscopy procedure)
  • result of breath tests.(the end of enrollment)

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dong Yang

Assisted Investigator

Jilin University

研究点 (1)

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