A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2031-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer Common Bile Duct Diseases Periampullary Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The way of surgery.

Study Groups

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laparoscopic pancreaticoduodenectomy group

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

Group Type OTHER

laparoscopic pancreaticoduodenectomy

Intervention Type PROCEDURE

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

Group Type OTHER

Robot Pancreaticoduodenectomy

Intervention Type 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.

Interventions

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laparoscopic pancreaticoduodenectomy

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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No