Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
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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: Early Gastric Cancer. Basic parameters: 18 years — 75 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 for Gastric Mucosal Lesions
Overview
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.
Interventions
- 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 - 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 (4)
- Specificity [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.]
- 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.]
- Positive Predictive Value (PPV) [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]
- Nnegative predictive value (NPV) [Time frame: The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.]
Eligibility criteria
Inclusion criteria
- All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.
Exclusion criteria
- lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
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-crossover
Study locations
China · 1 center
- The First Affiliated Hospital of Naval Medical University — Shanghai
Identifiers
NCT: NCT07507071 · pCLE vs. Pathological Biopsy