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The goal of this clinical trial is to learn if the EndoScell Scanner (ES) imaging system can accurately assess tumor-free surgical margins during surgery for adenocarcinoma of the esophagogastric junction (AEG), compared with standard frozen-section pathology.
The main questions it aims to answer are:
Researchers will compare an ES-assisted surgical arm with a conventional frozen-section arm to see if ES improves margin accuracy, shortens operative time, and increases the rate of complete (R0) tumor removal.
Participants will
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ES group | Experimental | ES-assisted surgery |
|
| FS Group | No Intervention | Frozen Section without ES scanning |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoSCell System | Device | EndoSCell Scaner (ES) is a new type of intraoperative cell-level fluorescence-guided imaging technology that can be used for direct and rapid intraoperative tissue cell interpretation. This technology uses a handheld cell microscope system to magnify local tissue by about 1280 times, and can perform rapid real-time scanning and imaging of in vivo or excised ex vivo tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy | Using paraffin pathology as the gold standard, the accuracy of ES system and frozen pathology for AEG resection margin was evaluated: Accuracy Rate = true positive + true negative/total number of samples. | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of R0 resection rate | The proportion of surgical resection specimens without residual tumor at the resection margin using paraffin pathology as the gold standard. | 7days after the surgery |
| Positive margin rate |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of ES interpretation in different Siewert classifications (type II vs. type III) | Accuracy of ES interpretation in different Siewert classifications (type II vs. type III) | 7days after the surgery |
Inclusion Criteria:
Including patients with Siewert type II and III AEG; Including patients in cT1 stage (recommended esophageal resection margin distance ≥1.5cm) and cT2 and above (recommended esophageal resection margin distance ≥3cm);
Exclusion Criteria:
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|
Using paraffin pathology as the gold standard, the proportion of ES interpretation as positive but frozen pathology showing negative
| 7days after the surgery |
| Evaluation of the actual resection margin distance during ES-assisted AEG | Evaluation of the actual resection margin distance during ES-assisted AEG | 7days after the surgery |
| Evaluate the sensitivity, specificity, PPV, and NPV of ES technology | Evaluate the sensitivity, specificity, PPV, and NPV of ES technology | 7days after the surgery |
| Evaluation of the consistency between ES technique and frozen pathology | Evaluation of the consistency between ES technique and frozen pathology | 7days after the surgery |
| Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery | Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery | 6, 12 months, and 2 years after surgery |
| Evaluation of the time efficiency of ES and frozen pathology | ES real-time interpretation time vs frozen pathology result time | 7days after the surgery |
| Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; | Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; | 7days after the surgery |