Adenocarcinoma of the Esophagogastric Junction
Conditions
Keywords
AEG resection, fluorescent, microscope
Brief summary
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: * Is ES non-inferior to intraoperative frozen-section pathology in identifying positive or negative tumor margins? * Does ES shorten the time needed for margin assessment and reduce the number of additional tissue resections required? 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 * undergo standard AEG resection with randomized assignment to either ES or frozen-section margin checks; * allow collection of margin tissue samples for ES, frozen-section, and final paraffin pathology; * attend routine follow-up visits for up to 2 years to monitor for local recurrence.
Interventions
DEVICEEndoSCell System
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.
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients clinically diagnosed with adenocarcinoma of the esophagogastric junction (AEG): 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); * Plan to receive surgical resection of AEG; * Patients voluntarily participated in this study and signed the informed consent form;
Exclusion criteria
* Patients who are allergic to methylene blue and fluorescein sodium; * Patients with severe cardiovascular or circulatory system diseases and cannot tolerate surgery; * Participated in other clinical trials of research drugs or devices in the past month; * Unable to understand the test requirements or unable to complete the study follow-up plan; * Pregnant and lactating women; * Patients who are unable to complete follow-up due to mental illness, cognitive or emotional disorders; * Subjects who are considered by the researchers to be unsuitable for participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy | intraoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of R0 resection rate | 7days after the surgery | The proportion of surgical resection specimens without residual tumor at the resection margin using paraffin pathology as the gold standard. |
| Positive margin rate | 7days after the surgery | Using paraffin pathology as the gold standard, the proportion of ES interpretation as positive but frozen pathology showing negative |
| Evaluation of the actual resection margin distance during ES-assisted AEG | 7days after the surgery | Evaluation of the actual resection margin distance during ES-assisted AEG |
| Evaluate the sensitivity, specificity, PPV, and NPV of ES technology | 7days after the surgery | Evaluate the sensitivity, specificity, PPV, and NPV of ES technology |
| Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery | 6, 12 months, and 2 years after surgery | Postoperative recurrence: evaluate the anastomotic recurrence rate at 6, 12 months, and 2 years after surgery |
| Evaluation of the time efficiency of ES and frozen pathology | 7days after the surgery | ES real-time interpretation time vs frozen pathology result time |
| Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; | 7days after the surgery | Evaluate the number of timely adjustments to the resection range due to the interpretation of ES technology; |
| Evaluation of the consistency between ES technique and frozen pathology | 7days after the surgery | Evaluation of the consistency between ES technique and frozen pathology |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of ES interpretation in different Siewert classifications (type II vs. type III) | 7days after the surgery | Accuracy of ES interpretation in different Siewert classifications (type II vs. type III) |
Outcome results
None listed