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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04211948
Other study ID # HBP-RWR-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 1, 2019
Est. completion date December 2024

Study information

Verified date April 2021
Source Ruijin Hospital
Contact Kai Qin, Doctor
Phone 0086-(0)21-64370045
Email qinkai310@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
robotic surgery
Pancreatectomy with robotic assisted system
open surgery
Traditional open pancreatectomy

Locations

Country Name City State
China Shanghai Ruijin Hospital Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Ruijin Hospital Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

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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