A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: laparoscopic pancreaticoduodenectomy, Robot Pancreaticoduodenectomy.
- Who it may be relevant to
- Registry conditions: Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
Overview
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
- Procedure laparoscopic pancreaticoduodenectomy
The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure. - Procedure 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
- Rate of long-term Survival [Time frame: 3 years]
Secondary outcome measures (2)
- Unplanned re-admission rate after discharge within 30 days [Time frame: 3 months]
- Incidence of postoperative complications [Time frame: 2 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05755607 · USC-4310-3