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This study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.
The overall prognosis of pancreatic cancer is poor. For resectable patients, adjuvant chemotherapy is performed after surgery, which has become the standard and standard treatment recommended by various guidelines. Preoperative neoadjuvant therapy is proved to improve the R0 resection rate and reduce the lymph node metastasis rate, thus prolonging the postoperative recurrence-free survival time and increasing the survival benefit of patients. But despite adequate preoperative and postoperative treatment, the patient benefit remains limited. In pancreatic cancer surgery, improving the R0 resection rate, increasing the positive lymph node resection rate, and accurately identifying small metastases to accurately stage, can improve the prognosis of patients to a certain extent. Therefore, this study intends to design the prospective, exploratory, single center clinical study, using targeted EGFR fluorescence imaging agent (anti-EGFR-IR800CW) and fluorescent navigation technology, in its lymph node tracing, intraoperative tumor localization, accurate determination of resection margin, and explore its clinical significance in radical surgical resection of pancreatic cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | The patient underwent Da Vinci robot or fluorescent laparoscopic-assisted radical resection of pancreatic cancer. The day before the operation, anti-EGFR antibody-IR800CW imaging agent was injected into the vein, and the fluorescence test was performed to evaluate the imaging of the primary lesions of the pancreas and the intra-abdominal lymph nodes. And to evaluate for the presence of imaging lesions in the liver, peritoneum, pelvic cavity, etc. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of fluorescent developer (anti-EGFR-IR800CW) | Diagnostic Test | The patient underwent Da Vinci robot or fluorescent laparoscopy-assisted radical resection of pancreatic cancer, and anti-EGFR antibody-IR800CW imaging agent was injected in the day before surgery, and fluorescence detection was performed |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy and sensitivity of the imaging agent | Accuracy and sensitivity of anti-EGFR antibody-IR800CW imaging technology of primary pancreatic lesions and metastatic lymph nodes in radical resection of pancreatic cancer | 1 month after enrolled |
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Inclusion Criteria:
Exclusion Criteria:
1. Combined diseases and medical history:
2. There are surgical contraindications;
3. Study Treatment-Related to:
4. According to the discretion of the investigator, subjects with serious hazards to subject safety or concomitant diseases completing the study, or no other reasons for the enrollment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tingbo Liang, PhD | Contact | +86 19941463683 | liangtingbo@zju.edu.cn | |
| Yiwen Chen, MD | Contact | +86 15088682641 | cherry0705@zju.edu.cn |
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