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Not yet recruiting NCT07088744

Comparison of the Sensitivity of pCLE and Pathological Biopsy Before ESD

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Probe-based Confocal Laser Endomicroscopy, Pathological biopsy.
Who it may be relevant to
Registry conditions: Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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 endomicroscop
  • 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.

Primary outcome measures

  • Sensitivity [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]
Secondary outcome measures (2)
  • Accuracy [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.]
  • Specificity [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.]

Eligibility criteria

Inclusion criteria

  • patients aged 18 to 85 years who were scheduled for endoscopic submucosal dissection due to early-stage gastric cancer were consecutively enrolled.

Exclusion criteria

  • Severe cardiac or pulmonary dysfunction, impaired renal function, coagulopathy, pregnancy or lactation, allergy to fluorescein, and inability to provide informed consent.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

China · 4 centers
  • Guangxi Zhuang Autonomous Region People's Hospital — Nanning
  • Northern Theater Command Hospital — Shenyang
  • West China Hospital of Sichuan University — Chengdu
  • The First Affiliated Hospital of Naval Medical University — Shanghai

Identifiers

NCT: NCT07088744 · Optical biopsy-CLE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗