The Comparision of Minimally-invasive and Open Pancreaticoduodenectomy for Pancreatic Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Minimally-invasive pancreaticoduodenectomy
Procedure/SurgeryMinimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Open pancreaticoduodenectomy
Other interventionOpen pancreaticoduodenectomy for resection of pancreatic tumor
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Minimally-invasive PancreaticoduodenectomyExperimental treatment 1 intervention
Group B: Open PancreaticoduodenectomyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall complications
The proportion of all complications after operation accounted for the total number of patients
Time frame
Up to postoperative 30 days2
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 days3
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 days4
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 daysSecondary outcomes
1
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 weeksOther outcomes
1
progression-free survival
The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason.
Time frame
Up to postoperative 5 yearsSponsors and contacts
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Source ClinicalTrials.gov