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

Overview

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.

Full Title of Study: “A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

Detailed Description

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.

Interventions

  • Procedure: Extended Lymphadenectomy
    • Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes
  • Procedure: Standard Lymphadenectomy
    • Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes

Arms, Groups and Cohorts

  • Active Comparator: Standard lymphadenectomy
    • 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
  • Experimental: Extended lymphadenectomy
    • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 1 year overall survival rate
    • Time Frame: 1 year post-operation
    • 1 year overall survival rate
  • 3 years overall survival rate
    • Time Frame: 3 years post-operation
    • 3 years overall survival rate
  • 5 years overall survival rate
    • Time Frame: 5 years post-operation
    • 5 years overall survival rate

Secondary Measures

  • Postoperative Complications
    • Time Frame: Within 90 days or before discharge
    • pancreatic fistula, bile leakage, haemorrhage, DGE, etc
  • 1, 3 & 5 years disease free survival rate
    • Time Frame: 1, 3 & 5 years post-operation
    • 1, 3 & 5 years disease free survival rate

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ruijin Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Weishen WANG, Principal Investigator – Ruijin Hospital
  • Overall Official(s)
    • Jiancheng WANG, Dr, Study Director, Shanghai Ruijin Pancreatic Disease Center

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