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Clinical Trials/NCT05755594
NCT05755594
Not yet recruiting
Not Applicable

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

The First Affiliated Hospital of University of South China0 sites100 target enrollmentJune 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pancreatic Cancer
Sponsor
The First Affiliated Hospital of University of South China
Enrollment
100
Primary Endpoint
Rate of long-term Survival
Status
Not yet recruiting
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

Perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.

Registry
clinicaltrials.gov
Start Date
June 1, 2023
End Date
June 1, 2031
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
The First Affiliated Hospital of University of South China
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Rate of long-term Survival

Time Frame: 3 years

survival will be documented 3 years after surgery

Secondary Outcomes

  • Unplanned re-admission rate after discharge within 30 days(3 months)
  • Incidence of postoperative complications(2 months)

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