Clinical Study Between Robotic and Open Surgery in Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine whether robotic surgery has limitations in terms of patient age, tumor size, location, and vascular relationship when compared to open surgery for pancreatic cancer. Whether robotic surgery has advantages over intraoperative bleeding, operative time, postoperative complications (bleeding, infection, pancreatic fistula) and postoperative hospital stays compared to open surgery.And the differences in lymph nodes harvest and postoperative survival between two groups.

Official Title
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Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer

Conditions
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Pancreatic Ductal Adenocarcinoma, Minimally Invasive Surgery

Intervention / Treatment
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* Procedure: robotic surgery
* Procedure: open surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed pancreatic ductal adenocarcinoma Patients and their families volunteered to test and signed informed consent. Exclusion Criteria: Preoperative exclusion: Patients with metastasis (M1) Patients with tumor recurrence Patients with artery and/or vein invasion and can't perform radical resection and reconstruction Patients with poor cardiopulmonary function cannot tolerate surgery; receive neoadjuvant radiotherapy and chemotherapy before surgery; The patient or family member refuses to join the group; Pregnant patients Intraoperative exclusion: Intraoperative exploration of metastases in other parts besides the primary lesion Other organs malignant tumors metastasize to the pancreas Postoperative exclusion: pathology confirmed non-pancreatic ductal adenocarcinoma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: robotic pancreatectomy<br>robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) | Procedure: robotic surgery<br>* Pancreatectomy with robotic assisted system<br>|
| Active Comparator: open surgery<br>open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy) | Procedure: open surgery<br>* Traditional open pancreatectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year overall survival rate |  | 1 year post-operation | 
| 3 years overall survival rate |  | 3 years post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Complications | pancreatic fistula, bile leakage, hemorrhage, DGE, etc | Within 90 days or before discharge | 
| 1, 3years disease free survival rate |  | 1,3years post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic assisted surgery