A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

Sponsor

The First Affiliated Hospital of University of South China (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05755607

Collaborator

(none)

200

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Cancer Common Bile Duct Diseases Periampullary Carcinoma	Procedure: laparoscopic pancreaticoduodenectomy Procedure: Robot Pancreaticoduodenectomy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

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.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.

Masking:

Single (Outcomes Assessor)

Masking Description:

The way of surgery.

Primary Purpose:

Treatment

Official Title:

A Multicenter Prospective Randomized Controlled Study of Robot Pancreaticoduodenectomy Versus Laparoscopic Pancreaticoduodenectomy

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2028

Anticipated Study Completion Date :

Jul 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Other: laparoscopic pancreaticoduodenectomy group The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.	Procedure: laparoscopic pancreaticoduodenectomy The laparoscopic group will perform the surgical procedure using laparoscopic instruments, with three surgeons involved throughout the procedure.
Other: 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.	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.

Arm

Intervention/Treatment

Other: laparoscopic pancreaticoduodenectomy group

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

Procedure: laparoscopic pancreaticoduodenectomy

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

Other: 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.

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.

Outcome Measures

Primary Outcome Measures

Rate of long-term Survival [3 years]
Survival will be documented 3 years after surgery

Secondary Outcome Measures

Unplanned re-admission rate after discharge within 30 days [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
Incidence of postoperative complications [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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