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Trial Title:
A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
NCT ID:
NCT05755594
Condition:
Pancreatic Cancer
Common Bile Duct Diseases
Periampullary Carcinoma
Conditions: Official terms:
Bile Duct Diseases
Common Bile Duct Diseases
Conditions: Keywords:
Robot-assisted pancreaticoduodenectomy
Safety and Efficacy
randomized controlled trial
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Masking description:
The way of surgery.
Intervention:
Intervention type:
Procedure
Intervention name:
Robot-assisted Pancreaticoduodenectomy
Description:
By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci
robotic surgical system and assisted by another surgeon for the entire procedure
Arm group label:
Robot-assisted Pancreaticoduodenectomy
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
June 1, 2023
Completion date:
June 1, 2031
Lead sponsor:
Agency:
The First Affiliated Hospital of University of South China
Agency class:
Other
Source:
The First Affiliated Hospital of University of South China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755594
