Minimally-invasive pancreaticoduodenectomy: Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Open pancreaticoduodenectomy: Open pancreaticoduodenectomy for resection of pancreatic tumor
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Age: \>18yr, \<75yr
* Patients with pancreatic cancer or non-pancreatic cancers (biliary duct cancer or ampullary cancer) who underwent pancreatoduodenectomy
* Preoperative imaging assessment is resectable or borderline resectable
Exclusion Criteria:
* Benign tumors of the head of pancreas
* Enhanced CT diagnosis revealed that the excess of SMV was more than 180 degrees, or distant metastasis.
* conversion to laparotomy because of intraoperative difficulty
Primary outcome measure(s)
Overall complications — Up to postoperative 30 days The proportion of all complications after operation accounted for the total number of patients
Pancreatic fistula — Up to postoperative 30 days 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.
Intra-abdominal bleeding — Up to postoperative 30 days 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.
Intra-abdominal infection — Up to postoperative 30 days Positive cultures of collection of fluid or blood,or persistent fever necessitating treatment with antibiotics and positive detection in image test.
Trial sites (1)
Facility
City
Region
Status
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing
Beijing Municipality
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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