laparoscopic pancreaticoduodenectomy
ProcedureThe laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
NCT Number: NCT05755607
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the 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.
Time frame: 3 years
Survival will be documented 3 years after surgery
Time frame: 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
Time frame: 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
Contact information is provided by the study sponsor or research team.
Danjun Chen, PhD
CONTACT
(+86)13789353900
Guodong Chen, PhD
CONTACT
(+86)15211450345
The First Affiliated Hospital of University of South China
Other
A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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