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This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.
system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| system treatment | Patients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy. |
| |
| system treatment and Surgery | Patients receive synchronous resection of primary tumor and metastasis after system treatment. and treatment after surgery is based on the clinical decision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| system treatment and surgery | Procedure | to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments. |
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 5 years | |
| Number of Postoperative morbidity | Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation | Up to 90 days after operation |
| Measure | Description | Time Frame |
|---|---|---|
| number of Patients die from any cause during 90 days after operation | 5 years | |
| progression-free survival in subgroup analysis | liver metastasis type, grade, extrahepatic metastasis | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xianjun yu, MD | Contact | +86 21 64175590 | yuxianjun@fudanpci.org | |
| Heli Gao | Contact | +86 21 64175590 | gaoheli@fudanpci.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| system treatment | Other | to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment. |
|
| number of Postoperative mortality | Up to 90 days after operation |
|
| D009380 | Neoplasms, Nerve Tissue |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |