A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
- Conditions
- Periampullary CarcinomaPancreatic CancerCommon Bile Duct Diseases
- Interventions
- Procedure: laparoscopic pancreaticoduodenectomyProcedure: Robot Pancreaticoduodenectomy
- Registration Number
- NCT05755607
- Lead Sponsor
- The First Affiliated Hospital of University of South China
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparoscopic pancreaticoduodenectomy group laparoscopic pancreaticoduodenectomy The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. Robot Pancreaticoduodenectomy Robot 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.
- Primary Outcome Measures
Name Time Method Rate of long-term Survival 3 years Survival will be documented 3 years after surgery
- Secondary Outcome Measures
Name Time Method 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