Clinical trial · Observational
Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
Comparison of the Sensitivity of Probe-Based Confocal Laser Endomicroscopy and Pathological Biopsy for Gastric Mucosal Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The pathological biopsy of gastric lesions, performed prior to endoscopic submucosal dissection (ESD), is crucial for differentiating the pathological nature of the lesions and guiding treatment decisions. However, due to the impact of biopsy sampling, the sensitivity of the pathological biopsy is not optimal. The probe - based confocal laser endomicroscopy (pCLE) technique enables the real - time display of high-resolution microscopic images of the mucosal layer (with an amplification factor of up to 1000 times) through a slender optical fiber probe that can pass through the standard endoscope's working channel. It is an optical biopsy technique and has unique value in determining the pathological nature of gastric lesions. As the Digestive Endoscopy Center of Shanghai Changhai Hospital is a national-level pCLE application demonstration center, it has prospectively collected numerous cases of pCLE examinations of gastric mucosal lesions. The main purpose of this study is to retrospectively analyze these cases and compare the sensitivity and specificity of pathological biopsy and pCLE in differentiating the pathological nature of gastric mucosal lesions.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Gastric Cancer | Early Gastric Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pathological biopsy | Diagnostic Test | — | UNRESOLVED |
| Probe-based Confocal Laser Endomicroscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.
- description
- Sensitivity, also known as True Positive Rate (TPR), refers to the proportion of patients with early gastric cancer that can be correctly identified by a certain diagnostic technique. High sensitivity means that this detection method can minimize the risk of missed diagnoses to the greatest extent and is applicable for disease screening (such as infectious diseases and early cancer screening).
Secondary outcomes (4)
- measure
- Specificity
- timeFrame
- The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.
- description
- Specificity refers to the ability of a diagnostic test to accurately identify individuals without early gastric cancer (true negative, TN), namely, the proportion of individuals who are actually healthy and test negative.
- measure
- Accuracy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * All patients aged 18-75 who underwent pCLE examination and received ESD treatmen. Exclusion Criteria: * lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
References
Publications (0)
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