A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

The First Affiliated Hospital of University of South China

Status: Not yet enrolling

Conditions: Periampullary Carcinoma; Common Bile Duct Diseases; Pancreatic Cancer

Treatments: Procedure: Robot Pancreaticoduodenectomy; Procedure: laparoscopic pancreaticoduodenectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05755607

USC-4310-3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

laparoscopic pancreaticoduodenectomy group

Other group

Description:

The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.

Treatment:

Procedure: laparoscopic pancreaticoduodenectomy

Robot Pancreaticoduodenectomy

Other group

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.

Treatment:

Procedure: Robot Pancreaticoduodenectomy