NCT07507071

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 169 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study, the pathological results of ESD or surgical resection of large specimens were used as the gold standard. The sensitivity of preoperative confocal endomicroscopy examination and pathological biopsy for gastric mucosal cancerous lesions was compared. The study adopted a retrospective approach and invited three experts to conduct offline blind diagnoses of the confocal endoscopy images respectively. First, two experts independently diagnosed all the cases. For those cases with inconsistent diagnosis results, a third expert was then consulted for a final determination. Although it was a retrospective study, the cases included in the research were all prospectively and continuously included in a demonstration project.

Conditions

• Early Gastric Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Probe-based Confocal Laser Endomicroscopy	Description: Confocal Laser Endomicroscopy (CLE) is an advanced in vivo imaging technique that combines confocal microscopy with endoscopy, enabling real-time, microscopic visualization of tissues at a cellular level during endoscopic procedures. Probe-based CLE (pCLE) can enter the stomach cavity through the biopsy channel of the endoscope and observe the gastric mucosa. All patients scheduled for endoscopic submucosal dissection (ESD) of gastric lesions must undergo probe-based confocal laser endomicroscopy (pCLE) prior to the ESD procedure.
DIAGNOSTIC_TEST	Pathological biopsy	A pathological biopsy is a medical procedure that involves the removal of a small sample of tissue or cells from the body for microscopic examination. It is a crucial diagnostic tool used to identify diseases, particularly cancer, infections, inflammatory conditions, and other abnormalities.

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-04-10
• Completion: 2026-04-15
• First posted: 2026-04-02
• Last updated: 2026-04-02

Locations

1 site across 1 country: China