Minimally invasive pancreaticoduodenectomy remains one of the most challenging abdominal procedures. Safety and feasibility remain controversial when comparing minimally-invasive with open pancreaticoduodenectomy, especially for malignant tumors.The aim of this study was to compare minimally invasive and open pancreatoduodenectomy for short-term outcomes and long-term follow-up in a randomized trial.
This study is to compare the efficiency and safety between minimally invasive (including laparoscopic and robotic) and open pancreaticoduodenectomy for pancreatic cancer. We design a prospective randomized study. Patients with malignant pancreatic tumor who underwent pancreatoduodenectomy are recruited to the study. After obtaining informed consent, eligible patients are randomly allocated to minimally-invasive or open group before the operation day. The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate as well as disease free survival and overall survival.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Open pancreaticoduodenectomy for resection of pancreatic tumor
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGOverall complications
The proportion of all complications after operation accounted for the total number of patients
Time frame: Up to postoperative 30 days
Pancreatic fistula
The international study group (ISGPF) definition: A drain output of any measurable volume of fluid on or after postoperative day 3 with an amylase content greater than 3 times the serum amylase activity. Three different grades of postoperative fistula (grades A, B, C) are defined according to the clinical impact on the patient's hospital course.
Time frame: Up to postoperative 30 days
Intra-abdominal bleeding
The International Study Group of Pancreatic Surgery (ISGPS) definition: Blood loss through abdominal drains or nasogastric tube;hematemesis or melena; clinical deterioration of the patient; unexplained hypotension or tachycardia; or laboratory findings such as a decreasing hemoglobin concentration.
Time frame: Up to postoperative 30 days
Intra-abdominal infection
Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Time frame: Up to postoperative 30 days
Length of hospital stay (day)
Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Time frame: Up to postoperative 2 weeks
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