Clinical trial NCT05755607: A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
Official title: A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Cancer
Common Bile Duct Diseases
Periampullary Carcinoma
Keywords: Robot pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy
randomized controlled trial
Safety and Efficacy
Lead sponsor: The First Affiliated Hospital of University of South China
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of long-term Survival
timeFrame: 3 years
Secondary outcomes:
measure: Unplanned re-admission rate after discharge within 30 days
timeFrame: 3 months
measure: Incidence of postoperative complications
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital of University of South China
name: Guodong Chen, PhD
role: STUDY_CHAIR
References: