Pancreatic Carcinoma, Surgery
Conditions
Keywords
minimally-invasive pancreaticoduodenectomy, open pancreaticoduodenectomy, pancreatic cancer
Brief 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.
Detailed description
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.
Interventions
PROCEDUREMinimally-invasive pancreaticoduodenectomy
Minimally-invasive pancreaticoduodenectomy for resection of pancreatic tumor
Open pancreaticoduodenectomy for resection of pancreatic tumor
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay (day) | Up to postoperative 2 weeks | Participants will be followed for the duration of hospital stay, an expected average of 2 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| progression-free survival | Up to postoperative 5 years | The period between the beginning of treatment and the observation of disease progression or the occurrence of death for any reason. |
Countries
China
Contacts
Primary ContactMenghua Dai, MD
Outcome results
None listed