Skip to main content
Clinical Trials/NCT04211948
NCT04211948
Recruiting
N/A

Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer

Ruijin Hospital1 site in 1 country300 target enrollmentMarch 1, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pancreatic Ductal Adenocarcinoma
Sponsor
Ruijin Hospital
Enrollment
300
Locations
1
Primary Endpoint
3 years overall survival rate
Status
Recruiting
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2019
End Date
December 2024
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kai Qin

Principal Investigator

Ruijin Hospital

Eligibility Criteria

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

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

  • Postoperative Complications(Within 90 days or before discharge)
  • 1, 3years disease free survival rate(1,3years post-operation)

Study Sites (1)

Loading locations...

Similar Trials