NCT07088744

Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

Comparison of the Sensitivity of Probe-based Confocal Laser Endomicroscopy and Pathological Biopsy Before Endoscopic Submucosal Dissection

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 169 (estimated)
• Sponsor: Changhai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Pathological biopsy before endoscopic submucosal dissection (ESD) the gastric lesion plays an important role in differentiating the pathological nature of the lesion and guiding treatment decisions. However, due to the influence of the materials used, the sensitivity of pathological biopsy is not satisfactory. Confocal Laser Endomicroscopy (CLE) is a technology that integrates a confocal microscope into an endoscope. It enables the acquisition of high-resolution microscopic images of the mucosal layer in real-time (with a magnification of up to 1000 times), and it is an optical biopsy technique. It has unique value in the determination of the pathological nature of gastric lesions. The main purpose of this study is to compare the sensitivity of pathological biopsy and CLE in differentiating the pathological nature of gastric lesions.

Conditions

• Gastric Cancer (Diagnosis)
• Gastric High-grade Intraepithelial Neoplasia
• Gastric Low-grade Intraepithelial Neoplasia
• Gastritis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Probe-based Confocal Laser Endomicroscopy	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: 2025-07-30
• Primary completion: 2025-08-31
• Completion: 2025-09-15
• First posted: 2025-07-28
• Last updated: 2025-07-28

Locations

4 sites across 1 country: China