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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Changhai Hospital | OTHER |
| Second Affiliated Hospital, School of Medicine, Zhejiang University |
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This clinical trial is about the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma，which is a multicenter，prospective，ramdomized clinical trials.
The purpose of this clinical trial is for assessing the survival benefit of extended lymphadenectomy and nerve clearance versus standard lymphadenectomy in pancreaticoduodenectomy of pancreatic adenocarcinoma. And we will focus on the R0 resection using LEEPP(Leeds Pathology Protocol) methods to check whether the tumor is eradicated or not.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| extended lymphadenectomy and nerve clearance | Experimental | The investigators will implement the pancreaticoduodenectomy using the principle of "Total Peripancreas Excision" to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node. |
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| standard lymphadenectomy | Experimental | The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| extended lymphadenectomy and nerve clearance | Procedure | The investigators will implement the pancreaticoduodenectomy using the principle of "Total Peripancreas Excision" to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | The overall survival of the patients from the time of surgery until the date of pass-away. | From date of randomization until the date of death from any cause, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | The time of the surgery until the date of the local recurrence or metastasis. | From date of randomization until the date of first documented progression( local recurrence or metastasis), assessed up to 100 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenhui Lou, MD | Contact | +8664041990 | 2909 | lou.wenhui@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24368638 | Background | Jang JY, Kang MJ, Heo JS, Choi SH, Choi DW, Park SJ, Han SS, Yoon DS, Yu HC, Kang KJ, Kim SG, Kim SW. A prospective randomized controlled study comparing outcomes of standard resection and extended resection, including dissection of the nerve plexus and various lymph nodes, in patients with pancreatic head cancer. Ann Surg. 2014 Apr;259(4):656-64. doi: 10.1097/SLA.0000000000000384. |
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| OTHER |
| Jiangsu Provincial People's Hospital | OTHER |
| Second Affiliated Hospital, Sun Yat-Sen University | OTHER |
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| standard lymphadenectomy | Procedure | The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node. |
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