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The diagnostic value of a new type of confocal laser endoscope for gastric diseases

Diagnostic value of a new type of confocal endoscopy and marketed confocal endoscopy in patients with chronic atrophic gastritis and gastric cancer: a single center, retrospective and prospective study

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100042956
Enrollment
Unknown
Registered
2021-02-01
Start date
2021-02-23
Completion date
Unknown
Last updated
2021-05-17

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

Conditions

Chronic atrophic gastritis ,gastric cancer

Interventions

Sponsors

Wuhan Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1) Age of 18-75 years old, regardless of gender; 2) the result of electronic gastroscopy was suspected of atrophic gastritis or gastric cancer; 3) good compliance and can cooperate to complete the entire clinical trial; 4) the subject volunteered to participate in the trial, and the subject or its legal agent signed the informed consent.

Exclusion criteria

Exclusion criteria: 1) Active bleeding at the observation site; 2) patient with acute severe throat disease who cannot allow insertion of endoscope; 3) patient with organ stenosis who were difficult to complete endoscopy; 4) patient suspected of shock, esophageal and gastrointestinal perforation; 5) acute phase of corrosive esophageal injury; 6) patients who were taking or had a history of taking anti-thrombotic drugs; 7) severe heart disease such as severe arrhythmia, especially slow ventricular rate, acute myocardial infarction and severe heart failure; 8) severe lung diseases such as bronchial asthmatic attack, cardiopulmonary failure, etc.; 9) patient with severe complications or advanced malignant tumors; 10) patient who cannot tolerate general anesthesia; 11) pregnant women and lactating women; 12) allergy to sodium fluorescein solution; 13) in any case, if the researcher thought the patient was not suitable for this test (such as the patient did not want to avoid other tests, the patient was unwilling to accept the research plan, the expected value of patient was unrealistic or patient had obvious emotional problems).

Design outcomes

Primary

MeasureTime frame
confocal laser endomicroscopy imaging ;SEN, SPE, ACC, AUC of ROC;

Secondary

MeasureTime frame
Biopsy;

Countries

China

Contacts

Public ContactLin Rong

Wuhan Union Hospital

selinalin35@hotmail.com+86 13476023730

Outcome results

None listed

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