The aim of this study is to evaluate the advantage of mesenteric approach during pancreaticoduodenectomy (PD) for pancreatic ductal adenocarcinoma (PDAC). The design of this study is multicenter randomized clinical trial, comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.
Mesenteric approach starts from dissection of lymph nodes around the superior mesenteric artery (SMA) and finally performs Kocher's maneuver during PD. The aims of this approach are 1) decrease of intraoperative blood loss volume, 2) increase of R0 rate, and 3) prevention of squeezing cancer cells out into the vessels. However, there have been no evidence of the efficacy of this procedure. Therefore, the aim of this study is to evaluate the efficacy of mesenteric approach during PD for PDAC, by multicenter randomized clinical trial comparing oncological and surgical outcomes between mesenteric approach and conventional approach during PD for PDAC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
354
pancreaticoduodenectomy for pancreatic ductal adenocarcinoma
Kyusyu University
Fukuoka, Japan
Kansai Medical University
Hirakata, Japan
Hiroshima University
Hiroshima, Japan
overall survival
survival from surgery to death
Time frame: up to 48 months
operative time
time for operation
Time frame: up to 24 months
time for resection
time for resection
Time frame: up to 3 months
intraoperative blood loss
intraoperative blood loss volume
Time frame: up to 3 months
blood transfusion volume
transfusion volume required during operation
Time frame: up to 3 months
grade B/C pancreatic fistula rate
grade B/C pancreatic fistula rate according to International Study Group of Pancreatic Surgery (ISGPS) definition
Time frame: up to 3 months
rate of delayed gastric emptying
rate of delayed gastric emptying according to International Study Group of Pancreatic Surgery (ISGPS) definition
Time frame: up to 3 months
abdominal hemorrhage rate
abdominal hemorrhage rate according to International Study Group of Pancreatic Surgery (ISGPS) definition
Time frame: up to 3 months
all morbidity rate
rate of all postoperative complications
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Shimane University
Izumo, Japan
Kagoshima University
Kagoshima, Japan
Nara Medical University
Kashihara, Japan
Kumamoto University
Kumamoto, Japan
Nagoya University
Nagoya, Japan
Osaka Medical University
Osaka, Japan
Osaka University
Osaka, Japan
...and 5 more locations
Time frame: up to 3 months
mortality rate
rate of operative death
Time frame: up to 3 months
diarrhea rate
rate of postoperative rate
Time frame: up to 24 months
R0 rate
pathological R0 rate
Time frame: up to 3 months
R1 rate
pathological R1 rate
Time frame: up to 3 months
the closest length between surgical margin and cancer cell
the closest length between surgical margin and cancer cell if R0
Time frame: up to 3 months
number of harvested lymph nodes
number of harvested lymph nodes
Time frame: up to 3 months
number of metastatic lymph nodes
number of metastatic lymph nodes
Time frame: up to 3 months
lymph node ratio
number of metastatic lymph nodes divided by number of harvested lymph nodes
Time frame: up to 3 months
recurrence free survival
survival from operation date to recurrence date
Time frame: up to 24 months
site of initial recurrence
site of initial recurrence
Time frame: up to 24 months