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NCT Number: NCT05755607

A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

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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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic pancreaticoduodenectomy

Procedure

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

Robot Pancreaticoduodenectomy

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.

Primary outcomes

  1. Rate of long-term Survival

    Time frame: 3 years

    Survival will be documented 3 years after surgery

Secondary outcomes

  1. Unplanned re-admission rate after discharge within 30 days

    Time frame: 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

  2. Incidence of postoperative complications

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Danjun Chen, PhD

CONTACT

[email protected]

(+86)13789353900

Guodong Chen, PhD

CONTACT

[email protected]

(+86)15211450345

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of University of South China

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2031
First posted
Mar 6, 2023
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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