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

T

The First Affiliated Hospital of University of South China

Status

Not yet enrolling

Conditions

Periampullary Carcinoma
Common Bile Duct Diseases
Pancreatic Cancer

Treatments

Procedure: Robot-assisted Pancreaticoduodenectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT05755594
USC-4310

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Robot-assisted Pancreaticoduodenectomy
Other group
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
Treatment:
Procedure: Robot-assisted Pancreaticoduodenectomy

Trial contacts and locations

0

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Central trial contact

Guodong Chen, PhD; Danjun Chen, PhD

Data sourced from clinicaltrials.gov

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