Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- 3 years overall survival rate
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
robotic pancreatectomy
robotic pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)
Intervention: robotic surgery (Procedure)
open surgery
open pancreatectomy(including pancreaticoduodenectomy and distal pancreatectomy)
Intervention: open surgery (Procedure)
Outcomes
Primary Outcomes
3 years overall survival rate
Time Frame: 3 years post-operation
1 year overall survival rate
Time Frame: 1 year post-operation
Secondary Outcomes
- 1, 3years disease free survival rate(1,3years post-operation)
- Postoperative Complications(Within 90 days or before discharge)
Investigators
Kai Qin
Principal Investigator
Ruijin Hospital