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

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)

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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