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

Not Applicable

Not yet recruiting

• Conditions: Pancreatic Cancer; Periampullary Carcinoma; Common Bile Duct Diseases
• Interventions: Procedure: Robot-assisted Pancreaticoduodenectomy

• Registration Number: NCT05755594
• Lead Sponsor: The First Affiliated Hospital of University of South China

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.

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.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-02-23
• Last Update Submitted: 2023-02-23
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06
• Study Start: 2023-06-01
• Primary Completion: 2028-06-01
• Study Completion: 2031-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted Pancreaticoduodenectomy	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

Primary Outcome Measures

Name	Time	Method
Rate of long-term Survival	3 years	survival will be documented 3 years after surgery

Secondary Outcome Measures

Name	Time	Method
Unplanned re-admission rate after discharge within 30 days	3 months	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
Incidence of postoperative complications	2 months	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