Gastric Cancer (Diagnosis), Gastric High-grade Intraepithelial Neoplasia, Gastric Low-grade Intraepithelial Neoplasia, Gastritis
Conditions
Keywords
Confocal Laser Endomicroscopy, pathological biopsy
Brief summary
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_TESTProbe-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 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_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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 the true positive rate (TPR), refers to the proportion of individuals in the actual patient group that a diagnostic test can correctly identify as positive (i.e., accurately detect cases). High sensitivity means that this detection method can minimize the risk of missed diagnosis to the greatest extent and is suitable for screening diseases (such as infectious diseases and early cancer screening). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 the target disease (such as being ill or not ill). It is the ratio of the sum of true positives and true negatives to the total test population. |
| 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 correctly identify individuals who do not have the disease (true negative, TN), that is, the proportion of people who are actually not ill and have a negative test result. |
Countries
China
Contacts
Primary ContactZhaoshen Li, Ph.D
Outcome results
None listed