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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05755594
• Other study ID #: USC-4310
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: June 1, 2031

Study information

• Verified date: February 2023
• Source: The First Affiliated Hospital of University of South China
• Contact: Guodong Chen, PhD
• Phone: (+86)15211450345
• Email: Chenguodong[@]usc.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2031
• Est. primary completion date: June 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Diseases
• Common Bile Duct Diseases
• Pancreatic Cancer
• Periampullary Carcinoma

Intervention

Procedure:
• Robot-assisted Pancreaticoduodenectomy
By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of University of South China

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of long-term Survival	survival will be documented 3 years after surgery	3 years
Secondary	Unplanned re-admission rate after discharge within 30 days	Serious discomfort requiring re-admission within 30 days after discharge will be recorded, and the safety of the surgical method will be evaluated by this indicator	3 months
Secondary	Incidence of postoperative complications	During hospitalization, common complications of pancreaticoduodenectomy, such as postoperative pancreatic fistula, bile leak, gastrojejunostomy leak, and delayed gastric emptying, will be recorded according to the international diagnostic criteria to evaluate the short-term safety of this surgical approach	2 months