Pancreatoduodenectomy
Conditions
Keywords
2D and 3D Laparoscopic pancreatoduodenectomy
Brief summary
Pancreatic cancer is extremely malignant, with a low sensibility to chemotherapy and radiotherapy, and a poor prognosis. Surgical treatment is very important for pancreatic cancer. Laparoscopic pancreatoduodenectomy is a standard radical procedure we are going to compare and discuss the advantages of 2D and 3D Laparoscopic pancreatoduodenectomy in our RCT study.
Detailed description
This study is to compare the efficiency and safety between 2D laparoscopic pancreatoduodenectomy and 2D laparoscopic 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 2D laparoscopic or 3D laparoscopic group before the operation day . The outcomes evaluated were hospital stay, and blood loss, radicality of surgery, duration of operation and complication rate.
Interventions
PROCEDURE3D Laparoscopic pancreatoduodenectomy
Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
PROCEDURE2D Laparoscopic pancreatoduodenectomy
2D Laparoscopic pancreatoduodenectomy
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two parallel groups: 2DLaparoscopic pancreatoduodenectomy and 3DLaparoscopic pancreatoduodenectomy
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 survival | 60 month | overall survival duration after surgical treatment |
Secondary
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Operative time | 12 hours | Durtion of operation |
| 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. |
Contacts
Primary ContactCheng Ding, MD
Outcome results
None listed