Pancreatic Ductal Adenocarcinoma Clinical Trial
Official title:
Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2024 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Diagnosed pancreatic ductal adenocarcinoma - Patients and their families volunteered to test and signed informed consent. Exclusion Criteria: - Preoperative exclusion: 1. Patients with metastasis (M1) 2. Patients with tumor recurrence 3. Patients with artery and/or vein invasion and can't perform radical resection and reconstruction 4. Patients with poor cardiopulmonary function cannot tolerate surgery; 5. receive neoadjuvant radiotherapy and chemotherapy before surgery; 6. The patient or family member refuses to join the group; 7. Pregnant patients - Intraoperative exclusion: 1. Intraoperative exploration of metastases in other parts besides the primary lesion 2. Other organs malignant tumors metastasize to the pancreas - Postoperative exclusion: 1. pathology confirmed non-pancreatic ductal adenocarcinoma |
Country | Name | City | State |
---|---|---|---|
China | Shanghai Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital | Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 1 year overall survival rate | 1 year post-operation | ||
Primary | 3 years overall survival rate | 3 years post-operation | ||
Secondary | Postoperative Complications | pancreatic fistula, bile leakage, hemorrhage, DGE, etc | Within 90 days or before discharge | |
Secondary | 1, 3years disease free survival rate | 1,3years post-operation |
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