Patients who are scheduled to undergo pancreaticoduodenectomy for resectable or BR-PV pancreatic ductal adenocarcinoma
Conditions
Interventions
Interventional group: mesenteric approach, which starts from lymph node dissection around the superior mesenteric artery and performs Kocher'
s maneuver finally during pancreaticoduodenectomy
Control group: conventional approach, which starts from Kocher'
s maneuver and finally performs lymph node dissection around the superior mesenteric artery during pancreaticoduodenectomy
Sponsors
Second Department of Surgery, Wakayama Medical University
Osaka Medical University, Oosaka University, Kagoshima University, Kansai Medical University, Kyusyu University, Kinki University, Kumamoto University, Shiga Medical University, Shimane University, Tokyo Medical University, Toyama University, Nara Medical University, Nagoya University, Hiroshima University, Gunma Univesity, Tsukuba University, Nagasaki University, Tokyo Medical and Dental University, Yokohama City University, Chiba University, Kyoto Prefectural University, Tohoku University, St.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patient who are scheduled to undergo pancreaticoduodenectomy for resectable or BR-PV pancreatic ductal adenocarcinoma. 2)Patients whose ECOG performance status are 0 or 1. 3)Patients who are 20 years or older. 4)Patients who have adequate organ function. 5)Patients who understand sufficiently the study to provide written informed consent
Exclusion criteria
Exclusion criteria: 1)Patients who have severe ischemic cardiovascular disease 2)Patients who have liver cirrhsis or active hepatitis 3)Patients who need oxygen due to interstitial pneumonia or lung fibrosis 4)Patients who receive dialysis due to chronic renal failure 5)Patients who need surrounding organ resection 6)Patients who need artery reconstruction 7)Patients who are diagnosed as positive para-aortic lymph node metastases based on preoperative imaging 8)Patients who have active multiple cancer that is thought to influence the occurrence of adverse events 9)Patients who take steroid for the long period that is thought to influence the occurrence of adverse events 10)Patients who undergo laparoscopic or laparoscopy-assisted pancreaticoduodenectomy 11)Patients who cannot understant ths study due to psychotic disease or psychological symptoms 12)Patients whose preoperative biopsy tissues are diagnosed as other pathological findings than pancreatic ductal adenocarcinoma 13)Patients who underwent gastrectomy or colon/ rectum resection previously 14)Patients who have severe drug allergy to iodine and gadolinum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| operative time, time for resection, intraoperative blood loss, blood transfusion volume, grade B/C pancreatic fistula rate, DGE rate, abdominal hemorrhage rate, all morbidity rate, mortality rate, diarrhea rate, R0 rate, R1 rate, the closest length between surgical margin and cancer cell, number of harvesteed lymph nodes, number of metastatic lymph nodes, lymph node ratio, Recurrence free survival, site of initial recurrence | — |
Countries
Japan
Contacts
Public ContactHirono Seiko
Wakayama Medical University Second Department of Surgery
Outcome results
None listed