Should a Standard Lymphadenectomy Include the No. 16 Lymph Nodes for Patients With Pancreatic Head Adenocarcinoma.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma

Intervention / Treatment
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* Procedure: Extended Lymphadenectomy
* Procedure: Standard Lymphadenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic diagnosis of pancreatic ductal adenocarcinoma Signed the informed consents Exclusion Criteria: Pathologic diagnosis of other pancreatic cancers Pre-operative anti-cancer treatment Recurrence patients Patients with contraindication(hepatic/ respiratory/ renal dysfunction, etc ) Pre operative exam: Total bilirubin more than 250µmol/L AJCC stage IV Operation non radical

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard lymphadenectomy<br>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 | Procedure: Standard Lymphadenectomy<br>* Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes<br>|
| Experimental: Extended lymphadenectomy<br>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). | Procedure: Extended Lymphadenectomy<br>* Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 1, 3 & 5 years post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RCT, Standard lymphadenectomy, Extended lymphadenectomy, Pancreaticoduodenectomy