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The aim of this study is to determine whether para-aortic lymph nodes(No.16) should be included in the lymphadenectomy during the pancreatoduodenectomy in order to improve the long-term survival of patients with pancreatic head ductal adenocarcinoma.
Pancreatic cancer is now raised to the 7th leading cause of death. Surgical resection seems to be the unique curative therapy for pancreatic cancer. The pancreaticoduodenectomy is widely performed for the patients with pancreatic head cancer in recent decades. The lymphadenectomy is an indispensible procedure. In 2014, the International Study Group for Pancreatic Surgery (ISGPS) recommended a standard lymphadenectomy should include lymph node stations 5, 6, 8a, 12b1, 12b2, 12c, 13a, 13b, 14a, 14b, 17a, and 17b. However, no consensus was reached on Lymph node 16 in particular 16b1. There was no stronge evidence available concerning the impact on survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard lymphadenectomy | Active Comparator | Standard lymphadenectomy includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes harvested during the pancreaticoduodenectomy with CHILD's digestive reconstruction |
|
| Extended lymphadenectomy | Experimental | In addition to the standard lymphadenectomy, para-aortic lymph nodes (No16) is included, in particular No 16b1 lymph nodes (Lymph nodes along the psterior side of the pancreas between the aorta and inferior vena cava). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Lymphadenectomy | Procedure | Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1 year overall survival rate | 1 year overall survival rate | 1 year post-operation |
| 3 years overall survival rate | 3 years overall survival rate | 3 years post-operation |
| 5 years overall survival rate | 5 years overall survival rate | 5 years post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | pancreatic fistula, bile leakage, haemorrhage, DGE, etc | Within 90 days or before discharge |
| 1, 3 & 5 years disease free survival rate | 1, 3 & 5 years disease free survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiancheng WANG, Dr | Shanghai Ruijin Pancreatic Disease Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ruijin Hospital | Shanghai | Shanghai Municipality | 200025 | China |
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| Standard Lymphadenectomy | Procedure | Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes |
|
| 1, 3 & 5 years post-operation |