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The value of confocal laser endomicroscopy in the diagnosis of Helicobacter pylori infection in patients with Atrophic gastritis

The value of confocal laser endomicroscopy in the diagnosis of Helicobacter pylori infection in patients with Atrophic gastritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300073229
Enrollment
Unknown
Registered
2023-07-04
Start date
2023-06-30
Completion date
Unknown
Last updated
2023-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter pylori infection

Interventions

Gold Standard:1) For patients undergoing gastroscopy, the rapid urease test (RUT) of Gastric mucosa tissue, tissue section staining or bacterial culture are positive in any of the three items, and one
The test results of both specimens were negative and were determined to be negative
Note: Routine staining of Gastric mucosa (H&E stain) can usually effectively diagnose HP infection. When the histology of Gastric mucosa in patients shows chronic active inflammation and the routine s
2) UBT (13C or 14C) is the most recommended non-invasive diagnostic method for HP infection in clinical practice. Its results indicate that one of the two specimens tested positive, indicating a posit
3) Monoclonal fecal antigen test will be used as an alternative to UBT, while serological test is mainly used for epidemiological investigation and not as a diagnostic method for current HP infection.

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The diagnosis meets the diagnostic criteria of western medicine: the clinical manifestations are dyspepsia symptoms such as upper abdominal fullness, upper abdominal pain, acid regurgitation, Heartburn and anorexia, without specificity, and the endoscopic diagnostic criteria refer to the Endoscopic Classification and Grading Standards for Chronic Gastritis (2004 Edition) [17] and the trial treatment opinions. Pathological diagnosis criteria refer to Atrophic gastritis diagnosed in the 2012 Chinese Consensus on Chronic Gastritis [16]; 2. Age: 20-75 years old; 3. Those who have gone to the Digestive Endoscopy Center of Central South Hospital of Wuhan University since 2021. 4. Those who have completed confocal microscopy endoscopy examination.

Exclusion criteria

Exclusion criteria: 1. Patients with concomitant peptic ulcer and severe gastrointestinal bleeding; 2. Patients with concurrent abdominal infection and intestinal obstruction; 3. Patients with severe heart, liver, and kidney dysfunction; 4. Pregnant and lactating women; 5. Allergic constitution or Drug allergy; 6. Those who have recently (within one month) used antibiotics; 7. The patient has Mental disorder and cannot cooperate to complete the study;

Design outcomes

Primary

MeasureTime frame
Consistency of confocal endoscopy and clinical diagnostic criteria in diagnosis of Atrophic gastritis;

Secondary

MeasureTime frame
Sensitivity,SEN;Specificity,SPE;positive predictive value ,PPV;negative predictive value,NPV;The eradication rate of HP infection in Atrophic gastritis patients;

Countries

China

Contacts

Public ContactJing Liu

Zhongnan Hospital of Wuhan University

jinming@biopsee.cn+86 189 7162 2466

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026