A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe First Affiliated Hospital of University of South China

About this trial

Further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. In this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.

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

Single group

Treatments tested in this trial

  • Robot-assisted Pancreaticoduodenectomy

    Procedure/Surgery

    By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Robot-assisted 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

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