Pancreatic invasive ductal adenocarcinoma
Conditions
Interventions
Intervention is defined as radical primary resection (pancreaticoduodenectomy or distal pancreatectomy) and regional lymph node dissection from the start to the end of surgery. Regional lymph node is
Sponsors
University of Toyama
Japan Pancreas Society Japan Oncology Network in Hepatobiliary and Pancreas
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: #Pancreatic invasive ductal adenocarcinoma #Resectable primary tumor #NO history of upper abdominal surgery #Reginal lymph node dissection possible by imaging diagnosis #Negative peritoneal cytology #Neoadjuvant chemotherapy #Indication for radical primary tumor resection within 28 days after completion of preoperative chemotherapy #Surgical operation: pancreatic head cancer (pancreaticoduodenectomy), pancreatic body and tail cancer (distal pancreatectomy) #Pancreatic invasive ductal adenocarcinoma #Resectable primary tumor #NO history of upper abdominal surgery #Reginal lymph node dissection possible by imaging diagnosis #Negative peritoneal cytology #Neoadjuvant chemotherapy #Indication for radical primary tumor resection within 28 days after completion of preoperative chemotherapy #Surgical operation: pancreatic head cancer (pancreaticoduodenectomy), pancreatic body and tail cancer (distal pancreatectomy) #Performance Status (ECOG) 0-1
Exclusion criteria
Exclusion criteria: #Active synchronous cancers #Severe complication #Inability to safely perform protocol surgery #Pretreatment other than protocol neoadjuvant chemotherapy #Pregnant, lactating woman or possible pregnancy #Psychiatric illness that interferes with daily life
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of metastases in each lymph node in the standard NAC cohort patients who met the primary analysis criteria. | — |
Secondary
| Measure | Time frame |
|---|---|
| -The index of lymph node dissection in each lymph node in the standard NAC cohort patients who met the primary analysis criteria (percentage of lymph node metastasis x 3-year recurrence free survival, or percentage of lymph node metastasis x 5-year recurrence free survival). -1,2,3,4,5-year recurrence-free survival rate and overall survival rate, recurrence-free survival , overall survival, disease-specific survival, disease-specific survival rate, postoperative complications, site of recurrence. -Percentage of metastases in each lymph node, and the index of lymph node dissection (percentage of lymph node metastasis x 3-year recurrence free survival, or percentage of lymph node metastasis x 5-year recurrence free survival) in each lymph node about non-standard cohort patients or in standard NAC cohort patients who did not meet the primary analysis criteria. | — |
Countries
Japan
Contacts
Public ContactKatsuhisa Hirano
University of Toyama Department of Surgery and Science
Outcome results
None listed