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Probe-based Confocal Laser Endomicroscopy in the Differentiation of Early Gastric Cancer: A Novel Criteria Establishment and Validation Study

A Bidirectional Study of Probe-Based Confocal Laser Endomicroscopy (pCLE) in Assessing the Degree of Differentiation in Early Gastric Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600126052
Enrollment
Unknown
Registered
2026-06-03
Start date
2025-03-17
Completion date
Unknown
Last updated
2026-06-08

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

Conditions

early gastric cancer

Interventions

Gold Standard:Histopathological examination
Index test:Probe-based confocal laser endomicroscopy, pCLE

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The lesion is located in the stomach. 2. Patients with pathologically confirmed early gastric cancer. 3. Confocal endoscopy performed before endoscopic treatment or surgery. 4. Complete offline pCLE images and magnifying endoscopy images are stored in the endoscopy system and can be retrieved.

Exclusion criteria

Exclusion criteria: 1. Lesions located in other parts of the digestive tract other than the stomach, or patients with advanced cancer. 2. Patients who are unsuitable for or do not consent to undergo confocal examination. 3. Pathological results that do not meet the diagnostic criteria for early gastric cancer. 4. Missing pCLE images, or lack of correspondence between magnifying endoscopy images and pCLE images.

Design outcomes

Primary

MeasureTime frame
Accuracy;—

Secondary

MeasureTime frame
Sensitivity;Specificity;Positive predictive value;Negative Predictive Value;—

Countries

China

Contacts

Public ContactChang Ying

Zhongnan Hospital of Wuhan University

changying@whu.edu.cn+86 177 8614 1805

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026