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NCT07507071Not yet recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
169 (estimated)
First submitted
27 Jan 2026
Start date
30 Mar 2026
Primary completion date
10 Apr 2026
Lead sponsor
Changhai Hospital
NCT number
NCT07507071

What you commit to

  • Study type: Observational
  • Planned participants: 169
  • From 30 Mar 2026 to the primary completion date, 10 Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.

Who the study is looking for

  • All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated Hospital of Naval Medical University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.