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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pancreatic Cancer, Common Bile Duct Diseases, Periampullary Carcinoma

Intervention / Treatment
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* Procedure: Robot-assisted Pancreaticoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Robot-assisted Pancreaticoduodenectomy<br>By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure | Procedure: Robot-assisted Pancreaticoduodenectomy<br>* By performing pancreaticoduodenectomy on the subject using the latest generation Da Vinci robotic surgical system and assisted by another surgeon for the entire procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of long-term Survival | survival will be documented 3 years after surgery | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robot-assisted pancreaticoduodenectomy, Safety and Efficacy, randomized controlled trial