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A Multicenter Prospective Randomized Controlled Study of RPD Versus LPD

ConditionsPancreatic CancerCommon Bile Duct DiseasesPeriampullary Carcinoma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe First Affiliated Hospital of University of South China

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • laparoscopic pancreaticoduodenectomy

    Procedure/Surgery

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

  • Robot Pancreaticoduodenectomy

    Procedure/Surgery

    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 groups

200 Participants
are divided into 2 treatment groups
Group A: laparoscopic pancreaticoduodenectomy groupOther 1 intervention
Group B: Robot PancreaticoduodenectomyOther 1 intervention

Trial outcomes

Primary outcomes

1

Rate of long-term Survival

Survival will be documented 3 years after surgery

Time frame
3 years

Secondary outcomes

1

Unplanned re-admission rate after discharge within 30 days

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

Time frame
3 months
2

Incidence of postoperative complications

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

Time frame
2 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of University of South China

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: