Early Gastric Cancer
Conditions
Keywords
Pathological biopsy, Early gastric cancer, High-grade intraepithelial neoplasia, Probe-based confocal Laser endomicroscopy, Endoscopic submucosal dissection
Brief summary
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_TESTProbe-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 endomicroscopy (pCLE) prior to the ESD procedure.
DIAGNOSTIC_TESTPathological 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
Changhai Hospital
Study design
Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation. | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | The pathological results can be obtained within 10 working days after ESD treatment, which can be used for specific calculations. | 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. |
| Accuracy | The pathological results can be obtained within 10 working days after ESD treatment, which can be used for the calculation of 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. |
| Positive Predictive Value (PPV) | The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation. | 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. |
| Nnegative predictive value (NPV) | The pathological results can be obtained within 10 working days after ESD treatment, which can be used for sensitivity calculation. | The definition of NPV is the probability that a lesion diagnosed as a non-cancerous lesion is actually non-cancerous. |
Countries
China
Contacts
CONTACTZhaoshen Li, Ph.D
CONTACTPeng Pan, M.D
Outcome results
None listed