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Trial Title:
A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD
NCT ID:
NCT05755607
Condition:
Pancreatic Cancer
Common Bile Duct Diseases
Periampullary Carcinoma
Conditions: Official terms:
Bile Duct Diseases
Common Bile Duct Diseases
Conditions: Keywords:
Robot pancreaticoduodenectomy
laparoscopic pancreaticoduodenectomy
randomized controlled trial
Safety and Efficacy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Outcomes Assessor)
Masking description:
The way of surgery.
Intervention:
Intervention type:
Procedure
Intervention name:
laparoscopic pancreaticoduodenectomy
Description:
The laparoscopic group will perform the surgical procedure using laparoscopic
instruments, with three surgeons involved throughout the procedure.
Arm group label:
laparoscopic pancreaticoduodenectomy group
Intervention type:
Procedure
Intervention name:
Robot Pancreaticoduodenectomy
Description:
The robotic team will perform the surgery using the latest generation Da Vinci robotic
surgical system, with an additional surgeon assisting in the procedure.
Arm group label:
Robot Pancreaticoduodenectomy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
June 1, 2023
Completion date:
July 1, 2031
Lead sponsor:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Source:
The First Affiliated Hospital of University of South China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755607
