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Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

NCT07088744 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 169

Last updated 2025-07-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Changhai Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-30
Primary Completion
2025-08-31
Completion
2025-09-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07088744 on ClinicalTrials.gov