Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Extended Retroperitoneal Lymphadenectomy and Nerve Plexus Clearance Versus Standard Lymphadenectomy in Pancreaticoduodenectomy for Adenocarcinoma of the Pancreatic Head in a Chinese Population:A Multicenter, Open-label, Randomized Controlled Clinical Trial.

Conditions
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Pancreaticoduodenectomy

Intervention / Treatment
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* Procedure: extended lymphadenectomy and nerve clearance
* Procedure: standard lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years; Karnofsky performance>70; preoperative diagnosis as resectable pancreatic head cancer; patients' relative have signed consent form. Exclusion Criteria: also have severe cardiopulmonary disease, autoimmune disease, chronic renal failure disease; recurrent pancreatic tumor or unresectable tumor; benign pancreatic tumor; also have other malignant tumors.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: extended lymphadenectomy and nerve clearance<br>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. | Procedure: extended lymphadenectomy and nerve clearance<br>* 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.<br>|
| Experimental: standard lymphadenectomy<br>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. | Procedure: standard lymphadenectomy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extended retroperitoneal lymphadenectomy, Nerve plexus clearance, Survival benefit