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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic pancreaticoduodenectomy group | Other | The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. |
|
| Robot Pancreaticoduodenectomy | Other | The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic pancreaticoduodenectomy | Procedure | The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of long-term Survival | Survival will be documented 3 years after surgery | 3 years |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guodong Chen, PhD | Contact | (+86)15211450345 | Chenguodong@usc.edu.cn | |
| Danjun Chen, PhD | Contact | (+86)13789353900 | nhfykyb@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Guodong Chen, PhD | The First Affiliated Hospital of University of South China | Study Chair |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D003137 | Common Bile Duct Diseases |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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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.
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The way of surgery.
| Robot Pancreaticoduodenectomy | Procedure | The robotic team will perform the surgery using the latest generation Da Vinci robotic surgical system, with an additional surgeon assisting in the procedure. |
|
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 |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |