Comparison of the Sensitivity of pCLE and Pathological Biopsy for Gastric Mucosal Lesions
ConditionEarly Gastric Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorChanghai Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients aged 18-75 who underwent pCLE examination and received ESD treatmen.
Disqualifiers
lack of pre-ESD pathological biopsy results, and ESD pathology indicated advanced gastric cancer.
Trial population
The study population primarily consisted of patients who had undergone both preoperative pathological biopsy and pCLE examination and then received endoscopic submucosal dissection (ESD) treatment. As both pathological biopsy and pCLE struggle to achieve a perfect diagnosis, this study employed the pathological diagnosis obtained via ESD surgery as the gold standard to compare the sensitivity, specificity, and accuracy of pathological biopsy and pCLE in diagnosing early gastric cancer.
Trial design
Design model
Case-crossover
Time perspective
Retrospective
Treatments tested in this trial
Probe-based Confocal Laser Endomicroscopy
Diagnostic testDescription: 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.
Pathological biopsy
Diagnostic testA 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Sensitivity
Sensitivity, also known as True Positive Rate (TPR), refers to the proportion of patients with early gastric cancer that can be correctly identified by a certain diagnostic technique. High sensitivity means that this detection method can minimize the risk of missed diagnoses to the greatest extent and is applicable for disease screening (such as infectious diseases and early cancer screening).
Time frame
The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.Secondary outcomes
1
Specificity
Specificity refers to the ability of a diagnostic test to accurately identify individuals without early gastric cancer (true negative, TN), namely, the proportion of individuals who are actually healthy and test negative.
Time frame
The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations.2
Accuracy
Accuracy refers to a comprehensive indicator that measures the ability of a medical test or diagnostic method to correctly distinguish between early gastric cancer and non - cancerous lesions. It is the ratio of the sum of true positives and true negatives to the total test population.
Time frame
The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of accuracy.3
Positive Predictive Value (PPV)
PPV is an important indicator in diagnostic tests, used to assess the probability that a subject actually has early gastric cancer when the test result is positive. Here is a detailed explanation.
Time frame
The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.4
Nnegative predictive value (NPV)
The definition of NPV is the probability that a lesion diagnosed as a non-cancerous lesion is actually non-cancerous.
Time frame
The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation.Sponsors and contacts
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Source ClinicalTrials.gov
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