Mesenteric approach vs. conventional approach for pancreatic cancer during pancreaticoduodenectomy (MAPLE-PD trial)
- Conditions
- Patients who are scheduled to undergo pancreaticoduodenectomy for resectable or BR-PV pancreatic ductal adenocarcinoma
- Registration Number
- JPRN-UMIN000029615
- Lead Sponsor
- Second Department of Surgery, Wakayama Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 354
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method overall survival
- Secondary Outcome Measures
Name Time Method 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