A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pancreatic-cancer
Started Jun 2023
Longer than P75 for not_applicable pancreatic-cancer
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
March 6, 2023
February 1, 2023
5 years
February 23, 2023
February 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of long-term Survival
survival will be documented 3 years after surgery
3 years
Secondary Outcomes (2)
Unplanned re-admission rate after discharge within 30 days
3 months
Incidence of postoperative complications
2 months
Study Arms (1)
Robot-assisted Pancreaticoduodenectomy
OTHERBy performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure
Interventions
By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guodong Chen, PhD
The First Affiliated Hospital of University of South China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- The way of surgery.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
March 6, 2023
Study Start
June 1, 2023
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
June 1, 2031
Last Updated
March 6, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share