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

Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

Prospective Cohort Study Comparing Robotic and Open Surgery for Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04211948
• Other study ID #: HBP-RWR-001
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Minimally Invasive Surgery
• Pancreatic Ductal Adenocarcinoma

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