Clinical trial · Interventional
Comparison of pCLE and EB in Gastric Lesion Diagnosis
Comparison of Probe-based Confocal Laser Endomicroscopy and Traditional Endoscopic Biopsies in the Diagnosis of Gastric Cancer and Precancerous Lesions: a Prospective Multicenter Comparative Study
- 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)
This is a prospective multicenter comparative study, aiming to compare probe-based confocal laser endomicroscopy (pCLE) and endoscopic biopsies in the diagnosis of the whole specific gastric lesion especially for distinguishing low grade intraepithelial neoplasia (LGIN) from high grade intraepithelial neoplasia (HGIN) and create an endoscopic image database for the follow-up research.
Conditions
Conditions (4)
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 |
| Gastric Intraepithelial Neoplasia | Gastric Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| High Grade Intraepithelial Neoplasia | High Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Low Grade Intraepithelial Neoplasia | Low Grade Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pCLE-gastr | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- pCLE-gastr
- description
- pCLE will be used to acquire the images from the gastric tissue of the participants after preoperative fluorescein sodium allergy test (negative) and pre-ESD assessment，and before ESD resection.
- interventionNames
- Device: pCLE-gastr
Primary outcomes (1)
- measure
- Diagnostic accuracy of pCLE and endoscopic biopsy in diagnosing the whole gastric lesion
- timeFrame
- immediatly after the diagnostic result of biopsy, ESD and pCLE is available，or admission up to 2 months
- description
- Using the pathological diagnostic result as the criteria, the accuracy, sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) will be used to evaluate the diagnostic efficacy in diagnosing LGIN, HGIN and early gastric cancer.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Over 18 years old and under 75 years old; * Patients with pathological diagnosis of LGIN, HGIN or early gastric cancer after conventional endoscopy biopsy, whose lesion has clear boundaries under endoscopic observation and is to be admitted for ESD surgery; * Patients who meet the indications for endoscopic resection of early gastric cancer, or LGIN patients who intend to undergo ESD surgery; * Patients who are able to provide pathological specimens/sections of previous endoscopic biopsy (in principle, it should be a case of this center). Exclusion Criteria: * Patients with advanced gastric cancer or previous gastrectomy; * Patients with severe cardiopulmonary dysfunction, liver cirrhosis, renal dysfunction, acute gastrointestinal bleeding, esophageal-gastro varices, and coagulation disorders; * Patients who have a positive result in the fluorescein sodium allergy test; * Pregnant and lactating women; * Patients who have psychiatric disorders and are unable to cooperate with endoscopy or sign informed consent.
References
Publications (0)
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