Common Bile Duct Diseases, Pancreatic Cancer, Periampullary Carcinoma
Conditions
Keywords
Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy
Brief summary
laparoscopic pancreaticoduodenectomy(LPD) and Robot Pancreaticoduodenectomy (RPD), as two minimally invasive methods of pancreaticoduodenectomy(PD), have obvious advantages over traditional open pancreaticoduodenectomy(OPD) in terms of reducing surgical trauma and hospitalization time, but there are few studies on their perioperative safety and prognostic effects.However, there are few studies on the perioperative safety and prognostic effects of both procedures. In this trial, the perioperative data and prognosis of both procedures were collected and analyzed through a prospective, multicenter approach to investigate the advantages and disadvantages of both procedures.
Detailed description
In this trial, subjects proposed for PD were randomly divided into two groups, LPD and RPD, according to inclusion and exclusion criteria. Patients in both groups were operated and received perioperative management under the same surgical team and were operated according to the standard PD surgical approach. Subsequently, perioperative clinical data and long-term prognostic data of subjects in both groups will be collected and statistically analyzed to explore a better surgical approach.
Interventions
PROCEDURElaparoscopic pancreaticoduodenectomy
The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
PROCEDURERobot Pancreaticoduodenectomy
The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.
Sponsors
The First Affiliated Hospital of University of South China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The way of surgery.
Intervention model description
The key difference in treatment between the two groups is the surgical approach, with the LPD group undergoing laparoscopic-assisted pancreaticoduodenectomy and the RPD group undergoing robotic-assisted pancreaticoduodenectomy, with all treatments remaining the same except for the surgical approach.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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