Common Bile Duct Diseases, Pancreatic Cancer, Periampullary Carcinoma
Conditions
Keywords
Robot-assisted pancreaticoduodenectomy, Safety and Efficacy, randomized controlled trial
Brief summary
Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.
Detailed description
Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.
Interventions
By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure
Sponsors
The First Affiliated Hospital of University of South China
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
The way of surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Over 18 years old * Preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with Pancreaticoduodenectomy * No distant transfer * No significant vascular invasion was received
Exclusion criteria
* With tumors of other organs * Patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs * Patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery * Preoperative adjuvant therapy was given
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of long-term Survival | 3 years | survival will be documented 3 years after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unplanned re-admission rate after discharge within 30 days | 3 months | Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator |
| Incidence of postoperative complications | 2 months | During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach |
Contacts
Primary ContactGuodong Chen, PhD
Backup ContactDanjun Chen, PhD
Outcome results
None listed