Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
Starting soon
Conditions studied: Early Gastric Cancer
In brief
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.
Key facts
- Study ID
- NCT07507071
- Run by
- Changhai Hospital
- People needed
- 169
- Starts
- 2026-03-30
- Expected to finish
- 2026-04-15
- Last updated by the study team
- 2026-04-02
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.
You may not qualify if…
- lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
Where it is running
- The First Affiliated Hospital of Naval Medical University — Shanghai, China
Full record on ClinicalTrials.gov
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