A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy

Conditions
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Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma

Intervention / Treatment
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* Procedure: laparoscopic pancreaticoduodenectomy
* Procedure: Robot Pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: laparoscopic pancreaticoduodenectomy group<br>The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. | Procedure: laparoscopic pancreaticoduodenectomy<br>* The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.<br>|
| Other: Robot Pancreaticoduodenectomy<br>The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. | Procedure: Robot Pancreaticoduodenectomy<br>* The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of long-term Survival | Survival will be documented 3 years after surgery | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unplanned re-admission rate after discharge within 30 days | 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 | 3 months | 
| Incidence of postoperative complications | 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 | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot pancreaticoduodenectomy, laparoscopic pancreaticoduodenectomy, randomized controlled trial, Safety and Efficacy