A Prospective Randomized Controlled Study Comparing Standard and Extended Lymphadenectomy for Pancreatic Head Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Ductal Adenocarcinoma
- Sponsor
- Ruijin Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- 3 years overall survival rate
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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
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.
Investigators
Weishen WANG
Principal Investigator
Ruijin Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
1 year overall survival rate
Time Frame: 1 year post-operation
1 year overall survival rate
Secondary Outcomes
- Postoperative Complications(Within 90 days or before discharge)
- 1, 3 & 5 years disease free survival rate(1, 3 & 5 years post-operation)